Catheter insertion tray with integrated instructions

ABSTRACT

An improved medical procedure or catheterization tray included in an improved medical procedure or catheterization package. The improved medical procedure or catheterization tray is intuitively arranged and includes instructions printed thereon to improve the medical procedure or catheterization implementation and results. In one example, a catheterization package and catheterization tray has a layout and/or arrangement of components that may help reduce CAUTI rates by facilitating ease of use and aiding in proper aseptic technique during insertion. The medical procedure or catheterization package and/or medical procedure or catheterization tray may include various implements, compartments, and components necessary and/or helpful to the medical procedure or catheterization, including, for example, improved swabs and an improved compartment for holding the swabs.

PRIORITY

This application is a continuation-in-part of U.S. patent applicationSer. No. 15/029,613, filed Apr. 14, 2016, now U.S. Pat. No. 10,758,705,which is a U.S. national stage of International Patent Application No.PCT/US2014/060963, filed Oct. 16, 2014, which claims the benefit of U.S.Provisional Patent Application No. 61/891,496, filed Oct. 16, 2013, andU.S. Provisional Patent Application No. 62/015,206, filed Jun. 20, 2014,each of which is hereby incorporated herein by reference in itsentirety.

BACKGROUND

Urinary drainage systems are conventionally used in hospitals and healthcare facilities when it is necessary to facilitate, control, monitorurination of patients, and when it is necessary to collect urine from apatient. These urinary drainage systems permit the patient to remain inbed, without having to use a bedpan or be moved to use a bathroom.Urinary drainage systems may include a catheter (e.g., a urinarycatheter, such as an intermittent catheter or a Foley catheter), acollection container/bag (e.g., a bag made of a polymeric material orPVC film), a urine meter, tubing connecting the Foley catheter to thecollection container/bag or urine meter, and/or other equipment. Inoperation, the patient is first catheterized, and the catheter isconnected to the drainage container/bag and/or urine meter through alength of tubing (e.g., drainage tubing). The urine drains through thecatheter, the tubing, and then finally into the collection container/bagand/or urine meter. The urine may be moved from the catheter into thecollection bag solely due to gravitational forces. On average, a patientproduces about 80-90 mL of urine in 1 hour.

Accurate monitoring of urine helps the clinician detect irregularitiesin urine flow rate or volume that can signal to the clinician that thepatient is suffering certain problems. However, urine output cannot beaccurately measured if the drainage system attached to the Foleycatheter is not reliable, or if the Foley catheter and drainage systemare not properly used. Further, hospitals are using increasinglylower-profile beds in order to reduce the number of injuries sustainedfrom falls. With the adoption of lower profile beds, the amount ofheight available to allow the tubing to drain is decreased. Drainagetubing used in hospitals and associated venting systems have alsoundergone changes/revisions. Changes in venting combined withincreasingly lower profile hospital beds have created suboptimaldrainage performance. For example, urine has been observed pooling inthe tubing. This prevents accurate urine output and flow ratemeasurements, which are critical for many patients.

Currently, the second-most common form of Hospital Acquired Infection(HAI) is catheter-associated urinary tract infection (CAUTI). Hospitalsare interested in ways to cut their CAUTI rates by conforming to astrict aseptic technique as a standard of care. However, there are manyfactors that influence a hospital's ability to meet the standard ofcare. These factors include: health care practitioner/nurse experienceand training, patient factors (e.g., general health, weight, andanatomy), environmental factors, and tray layout as well as contents andinstructions/indicators. A catheterization package and/orcatheterization tray with components optimized to the procedure and anintuitive layout can increase compliance to aseptic technique,potentially reducing CAUTI rates.

There is a need in the healthcare field for a more reliable, safe, andeasy method for inserting a catheter, such as a urinary catheter, forexample an indwelling or intermittent catheter, into a patient. Moreparticularly, there is a need to provide a catheterization packageand/or a catheterization tray (e.g., a Foley catheter tray) thatimproves and standardizes the process for inserting a urinary catheter,such as an indwelling Foley catheter, into a patient.

The present disclosure provides a catheterization package, cathetertray, and drainage system configured to better meet patients' needs,improve reliability and ease of use, reduce incidents of CAUTI, improvesafety, and address other issues described above and elsewhere herein.

SUMMARY

Embodiments of, and enhancements for, packages, systems, trays,assemblies, devices, methods, etc. used for medical treatment generallyand catheterization, in particular, are described herein.

The objectives described herein can be met by providing an improvedmedical procedure package and/or tray (e.g., an improved catheterizationpackage and/or an improved catheterization tray). The improved medicalprocedure package may include the improved medical procedure traytherein, and the medical procedure tray may be intuitively arranged andmay include instructions or procedural indicators to improve the medicalprocedure implementation and results. The medical procedure packageand/or medical procedure tray may include various implements andcomponents necessary and/or helpful to the medical procedure. Forexample, an improved catheterization package may include an improvedcatheterization tray, povidone iodine swabs or swabsticks that allow forgreater coverage and saturation, hand sanitizer with improved efficacyand that enables single-handed usage, tubing that breaks up the surfacetension of the fluid in order to improve drainage, and/or othercomponents described herein.

According to various embodiments, the present disclosure provides acatheterization package and catheterization tray having a layout and/orarrangement of components that may help reduce CAUTI rates byfacilitating ease of use and aiding in proper aseptic technique duringinsertion. The present disclosure also provides methods ofcatheterization and use of a catheterization package and/orcatheterization tray that may facilitate easier and more sterilecatheterization to help reduce CAUTI rates. Further, the presentdisclosure provides a system that may improve drainage performance,which in turn: (1) helps to eliminate fluid in the drain tubing, and (2)increases the accuracy of urine measurements (e.g., measurements ofoutput and flow).

In some embodiments, a catheterization package is provided including acatheterization tray and a sterile wrap around the catheterization tray.The catheterization tray can include catheterization instructionsimprinted directly on the catheterization tray. The catheterization traycan also include a first section, a second section, and a third section,wherein in one or more partitions can separate at least the thirdsection from the first and second sections. The first section can hold adrainage system, the second section can hold a container containinglubricant, and the third section can hold a swab in an inclinedposition. The absorbent head of the swab can angle downwardly into awell of the third section and an elongate member of the swab can angleupwardly for gripping and removal of the swab.

In such embodiments, the catheterization package can further include aperi-care kit, a belly band, and a packaging label. The peri-care kitcan be packaged with the catheterization tray but outside the sterilewrap. One example of a suitable peri-care kit is disclosed in PCTApplication Publication No. WO 2016/126555, the disclosure of which isincorporated herein by reference in its entirety. The belly band can beoutside the sterile wrap holding the sterile wrap in a foldedconfiguration around the catheterization tray. The packaging label canbe outside the sterile wrap for identifying the catheterization package.

In such embodiments, the third section of the catheterization packagecan include a swab compartment, an overflow compartment, and a cornerstorage compartment holding a specimen container. The swab compartmentcan include the well and a channel configured to hold the swab. Thechannel can include at least two snap-in tabs to hold the swab in thechannel under the snap-in tabs, wherein each longitudinal side of thechannel includes at least one of the at least two snap-in tabs. Thechannel can be further configured to convey a fluid to the well when theswab is absent from the channel and the fluid is poured in the channel.The overflow compartment can be fluidly connected to the well throughthe channel.

In such embodiments, the one or more partitions of the catheterizationpackage separating the third section from the first and second sectionscan further separate the second section from the first section. Secondsection-separating partitions of the one or more partitions can have amaximum height equal to a height of the catheterization tray, wherein abottom of the second section can be elevated above a bottom of thecatheterization tray. Alternatively, the second section-separatingpartitions of the one or more partitions can have a maximum height lessthan the height of the catheterization tray, wherein the bottom of thesecond section and the bottom of the catheterization tray aresubstantially co-planar.

In some embodiments, a medical-procedure package is provided including atray with medical-procedure instructions imprinted directly on the tray,at least some of which instructions are revealed in step with steps ofthe medical procedure. The tray can include a first section, a secondsection, and a third section, wherein one or more partitions separate atleast the third section from the first and second sections. The tray canfurther include a drainage system, a container containing a lubricant,and one or more swabs. The first section can include at least thedrainage system, the second section can include at least the containercontaining the lubricant, and the third section includes at least theone or more swabs.

In such embodiments, the medical-procedure package can further include aspecimen container. The third section can include a swab compartment, anoverflow compartment, and a corner storage compartment including thespecimen container. The swab compartment can include a well and one ormore channels configured to respectively hold the one or more swabs withsnap-in tabs in the one or more channels. The one or more channels canalso be angled with respect to a bottom of the tray such that a handleend of each swab of the one or more swabs held under the snap-in tabs iselevated with respect to an absorbent-head end when the absorbent-headend is in the well. The overflow compartment can be fluidly connected tothe well through the one or more channels, wherein the one or morechannels can be further configured to convey a fluid poured therein tothe well when the one or more swabs are removed from the one or morechannels.

In such embodiments, the medical-procedure package can further include athird section-separating partition of the one or more partitions at awell-end of the swab compartment directly separating the well from thesecond section. Alternatively, a well-end of the swab compartment canshare with the tray an inner wall of the tray.

In such embodiments, the one or more partitions of the medical-procedurepackage separating the third section from the first and second sectionscan further separate the second section from the first section. Secondsection-separating partitions of the one or more partitions can have amaximum height equal to a height of the tray, wherein a bottom of thesecond section can be elevated above a bottom of the tray.Alternatively, the second section-separating partitions of the one ormore partitions can have a maximum height less than the height of thetray, wherein the bottom of the second section and the bottom of thetray are substantially co-planar.

In some embodiments, a catheterization package is provided including atray with instructions for a catheterization procedure imprinteddirectly on the tray, at least some of which instructions are revealedin step with steps of the catheterization procedure. The tray caninclude a first section, a second section, and a third section, whereinone or more partitions separate at least the third section from thefirst and second sections. The tray can further include a drainagesystem, a container containing a lubricant, a syringe of sterile liquid,such as water or, in some instances, saline, and a skin-preparation kit.The first section can include at least the drainage system, whichdrainage system can include a Foley catheter, drainage tubing, and adrainage bag. The second section can include at least the containercontaining the lubricant. The first section can include the syringe ofthe sterile liquid, such as sterile water, which syringe can beconfigured for inflating a balloon of the Foley catheter with thesterile water. According to certain embodiments, the water syringe canbe connected to the inflation port of the Foley catheter duringmanufacture of the assembly. Providing a pre-connected syringe to theFoley catheter can help minimize the number of steps required tocatheterize a patient. The third section can include at least theskin-preparation kit, which kit can include a package of an antisepticand one or more swabs.

In such embodiments, the catheterization package can further include aspecimen container and a label for the specimen container. The thirdsection can include a swab compartment, an overflow compartment, and acorner storage compartment including the specimen container. The swabcompartment can include a well and one or more channels configured torespectively hold the one or more swabs with snap-in tabs in the one ormore channels. The overflow compartment can be fluidly connected to thewell through the one or more channels, wherein the one or more channelscan be further configured to convey the antiseptic poured therein to thewell when the one or more swabs are removed from the one or morechannels. The package of the antiseptic can be placed over the swabcompartment, the overflow compartment, the corner storage compartment,or a combination thereof.

In such embodiments, the catheterization package can further include athird section-separating partition of the one or more partitions at awell-end of the swab compartment directly separating the well from thesecond section. Alternatively, a well-end of the swab compartment canshare with the tray an inner wall of the tray.

In such embodiments, the one or more partitions of the catheterizationpackage separating the third section from the first and second sectionscan further separate the second section from the first section. Secondsection-separating partitions of the one or more partitions can have amaximum height equal to a height of the tray, wherein a bottom of thesecond section can be elevated above a bottom of the tray.Alternatively, the second section-separating partitions of the one ormore partitions can have a maximum height less than the height of thetray, wherein the bottom of the second section and the bottom of thetray are substantially co-planar.

In such embodiments, the catheterization package can further include asterile wrap, a peri-care kit, a belly band, and a packaging label. Thesterile wrap can be in a folded configuration around the tray. Theperi-care kit can be packaged with the catheterization tray but outsidethe sterile wrap. The belly band can be outside the sterile wrap holdingthe sterile wrap in the folded configuration around the catheterizationtray. The belly band can also include instructions regarding how toorient the tray prior to opening the sterile wrap. The packaging labelcan be outside the sterile wrap for identifying the catheterizationpackage. In addition, the packaging label can include informationemphasizing key features of the catheterization package in a way that iseasy to read quickly.

In some embodiments, a catheterization package comprises acatheterization tray including a first compartment holding a drainagesystem; a second compartment holding a syringe; a third compartmentholding a swab in an inclined position such that an absorbent head ofthe swab is biased downwardly into a well of the third compartment andan elongate member of the swab angles upwardly for easier gripping andremoval; and catheterization instructions or procedural indicatorsimprinted directly on the catheterization tray. The catheterizationpackage may also include a sterile wrap (e.g., a CSR wrap) wrappedaround the catheterization tray. The absorbent head of the swab may beformed of absorbent foam, and the elongate member of the swab may have agenerally rectangular cross section with rounded edges. Thecatheterization package may also include a peri-care kit packaged withthe catheterization tray at a location outside the sterile wrap. Thecatheterization package may also include a belly band outside thesterile wrap, the belly band including an instruction or proceduralindicator regarding how to orient the catheterization tray prior toopening the sterile wrap. Additionally, the catheterization package mayinclude a packaging label outside the sterile wrap, wherein thepackaging label includes at least three sides folded into a differentplane from the top portion of the label that are visible when viewingthe catheterization package from one or more sides of thecatheterization package, and/or wherein the packaging label includesinformation features (e.g., information squares) that each emphasize akey feature of the catheterization package in a way that is easy to readquickly. The catheterization package may include an outer sealedcontainer or bag (e.g., a plastic, transparent bag) around the othercomponents to maintain sterility during shipping and storage.

In some embodiments, a medical procedure package comprises three or morecompartments holding implements useful for performance of the medicalprocedure and instructions/procedural indicators imprinted or includeddirectly on the medical procedure tray directing a user how to carry outsteps of the medical procedure, wherein the three or more compartmentsof the medical procedure tray, the instructions/procedural indicators,and implements are arranged in an arrangement such that the medicalprocedure proceeds intuitively from step to step based on thearrangement. The arrangement may include stacking various components orimplements (e.g., 2 to 20 implements/components or 4 to 10implements/components) on top of each other in the order that they areto be used (e.g., with components or implements to be used before othercomponents or implements being positioned on top of the other componentsor implements to be used later).

In some embodiments, a method of treating a patient comprises providinga medical procedure tray including three or more compartments includingimplements useful for performance of the medical procedure andinstructions/procedural indicators imprinted directly on the medicalprocedure tray directing a user how to carry out steps of the medicalprocedure. The method may also include performing the medical procedureon a patient while following the instructions/procedural indicatorsimprinted on the medical procedure tray. Three or more compartments ofthe medical procedure tray, the instructions/procedural indicators,and/or implements are arranged such that the medical procedure proceedsintuitively from step to step based on how they are arranged on/in themedical procedure tray.

In some embodiments, a method of catheterizing a patient comprisesproviding a catheterization package having a catheterization trayincluding a first compartment holding a drainage system including acatheter; a second compartment holding a swab in an inclined positionsuch that and absorbent head of the swab is biased downwardly into awell of the second compartment and an elongate member of the swab anglesupwardly; pouring an antiseptic solution into the well such that theabsorbent head is in contact with the antiseptic solution, using theswab to cleanse the patient in a region to be catheterized, andinserting a portion of a catheter into a urethra of the patient. Asealed container or bag may be disposed around the catheterization tray,and the method may include unsealing the sealed container or bag. Asterile wrap may be wrapped around the catheterization tray, and themethod may include unwrapping the sterile wrap prior to pouring anantiseptic solution into the well. The catheterization package may alsoinclude a peri-care kit located outside of the sterile wrap, and themethod may include using the peri-care kit to cleanse a portion of thepatient's perineum prior to unwrapping the sterile wrap. A belly bandmay be positioned outside the sterile wrap, the belly band may includean instruction/procedural indicator or instructions/proceduralindicators regarding how to properly orient the catheterization trayprior to opening the sterile wrap, and the method may include orientingthe tray according to the instruction(s)/procedural indicator(s) priorto unwrapping the sterile wrap.

In some embodiments, a method of manufacturing a catheterization packagecomprises providing a catheterization tray including a firstcompartment, a second compartment, a third compartment having aninclined portion of the bottom of the compartment with channels forholding a swab, and catheterization instructions/procedural indicatorsimprinted directly on the catheterization tray; wherein the firstcompartment, the second compartment, and the third compartment are eachat least partially separated from each other by partitions. The methodmay also include positioning a drainage system in the first compartment,a syringe in the second compartment, and a swab in the third compartmentsuch that an absorbent head of the swab is biased downwardly into a wellof the third compartment and an elongate member of the swab anglesupwardly for easier gripping and removal. The method may further includewrapping the catheterization tray in a sterile wrap and positioning abelly band around a portion of the sterile wrap, the belly bandincluding an instruction/procedural indicator or instructions/proceduralindicators regarding how to properly orient the catheterization trayprior to opening the sterile wrap. In addition, the method may includeadding a peri-care kit to the catheterization tray outside the bellyband and sterile wrap, the peri-care kit including a baggy with a zipperholding cleansing towelettes, hand sanitizer, andinstructions/procedural indicators for cleansing the patient. The methodmay include adding a document of detailed catheterization instructionsand/or procedural indicators to the catheterization package. Also, themethod may include placing a packaging label on top of thecatheterization package, the packaging label including at least threeside portions folded from the top portion, and/or placing a packaginglabel on top of the catheterization package, the packaging labelincluding an information feature or information features that eachemphasize one or more key features of the catheterization package in away that is easy to read quickly. The information feature or informationfeatures may be an information square or multiple information squares.The method may also include sealing (e.g., by heat sealing) atransparent plastic bag around the catheterization package.

In some embodiments, a catheterization system includes a container forsecuring components for a catheterization procedure. The container hasan outer shell defining a general shape of the container and a pluralityof compartments within the outer shell. Each of the plurality ofcompartments is separated from one or more adjacent compartments of theplurality of compartments by one or more partitions. The plurality ofcompartments include a first compartment sized and configured to containa catheter assembly and one or more secondary compartments separatedfrom the first compartment by the one or more partitions. At least oneof the one or more secondary compartments includes at least one partialpartition (e.g., a partition that includes a reduced height portion) ofthe one or more partitions.

In some embodiments, a catheterization system for performing acatheterization procedure is provided. The catheterization systemincludes a catheterization tray that has an outer shell defining ageneral shape of the container and a plurality of compartments withinthe outer shell. Each of the plurality of compartments is separated fromone or more adjacent compartments of the plurality of compartments byone or more partitions. The plurality of compartments may include afirst compartment containing a catheter assembly and one or moresecondary compartments separated from the first compartment by the oneor more partitions. At least one of the one or more secondarycompartments may include at least one partial partition (e.g., apartition that includes a reduced height portion) of the one or morepartitions. Additionally, the catheterization system includes one ormore swabs located in a second compartment of the one or more secondarycompartments.

DRAWINGS

The disclosed embodiments of, and enhancements for, packages, trays,devices, systems and methods can be better understood with reference tothe following drawings. Portions of the material in this patent documentare subject to copyright protection under the copyright laws of theUnited States and of other countries. The owner of the copyright rightshas no objection to the facsimile reproduction by anyone of the patentdocument or the patent disclosure, as it appears in the United StatesPatent and Trademark Office publicly available file or records, butotherwise reserves all copyright rights whatsoever.

FIG. 1 shows a top view of a medical procedure tray including integratedinstructions/procedural indicators in the form of a catheterizationtray.

FIG. 2 shows a top, front (or proximal), right perspective view of themedical procedure tray of FIG. 1.

FIG. 3 shows a right side elevation view of the medical procedure trayof FIG. 1.

FIG. 4 shows a back (or distal) side elevation view of the medicalprocedure tray of FIG. 1.

FIG. 5 shows a top view of another medical procedure tray includingintegrated instructions/procedural indicators in the form of acatheterization tray that is larger than the tray in FIG. 1.

FIG. 6A shows a top view of a swab or swabstick that may be included ina catheterization package and/or tray.

FIG. 6B shows a side perspective view of the swab or swabstick in FIG.6A.

FIG. 6C shows an end view of the swab or swab stick in FIG. 6A to showthe cross-sectional shape of the elongate member or stick.

FIG. 7A shows a top view of a swab or swabstick that may be included ina catheterization package and/or tray.

FIG. 7B shows a side perspective view of the swab or swabstick in FIG.7A.

FIG. 7C shows an end view of the swab or swabstick in FIG. 7A to showthe cross-sectional shape of the elongate member or stick, thecross-sectional shape being different from that shown in FIG. 6C.

FIG. 8 shows a top view of a swab compartment and small storage oroverflow compartment of a catheterization tray including swabs orswabsticks similar to the swab or swabstick shown in FIGS. 7A-7C,wherein one swab or swabstick is rotated approximately 90° to release itfrom the securement features of the swab compartment.

FIG. 9 shows a top view of a catheterization package sealed in a sealedbag and having a packaging label with information squares on a top andtwo sides thereof, the sides providing for easy viewing even if thecatheterization package were in a stack of other catheterizationpackages.

FIG. 10 shows a top, front perspective view of another catheterizationpackage (different from that shown in FIG. 9) sealed in a sealed bag andhaving a packaging label with information squares on a top and two sidesthereof (one side of which is visible), the sides providing for easyviewing even if the catheterization package were in a stack of othercatheterization packages.

FIG. 11 shows a top view of the catheterization package of FIG. 9outside of the sealed bag, but still having the same packaging labelthereon.

FIG. 12 shows a top, flattened view of the packaging label of thecatheterization package of FIG. 10 including lines added to show wherethe sides may be folded when placed over other components of acatheterization package prior to sealing the catheterization package ina sealed bag.

FIG. 13 shows a top view of a catheterization package (e.g., either thecatheterization package of FIG. 9 or FIG. 10) after the sealed bag andpackaging label have been removed, and showing detailedinstructions/procedural indicators document or directions for use (DFU)document thereon.

FIG. 14A shows a page of a document of detailed catheterizationinstructions/procedural indicators or directions for use (DFU) documentthat may be included in a catheterization package.

FIG. 14B shows another page of the document of detailed catheterizationinstructions/procedural indicators or directions for use (DFU) documentof FIG. 14A.

FIG. 14C shows another page of the document of detailed catheterizationinstructions/procedural indicators or directions for use (DFU) documentof FIG. 14A.

FIG. 14D shows another page of the document of detailed catheterizationinstructions/procedural indicators or directions for use (DFU) documentof FIG. 14A.

FIG. 15A shows a front side of a patient education informationsheet/pamphlet that may be included in a catheterization package.

FIG. 15B shows a back side of the patient education informationsheet/pamphlet of FIG. 15A.

FIG. 16 shows a top view of the catheterization package of FIG. 13without the detailed instructions/procedural indicators document ordirections for use (DFU) document, and showing a label or insert sheetthereon.

FIG. 17 shows a top view of a catheterization package (e.g., similar tothe catheterization package of FIG. 16) without the label or insertsheet, and showing a perineal care or peri-care kit/packet thereon.

FIG. 18 shows a top view of a catheterization package (e.g., similar tothe catheterization package of FIG. 16) without the label or insertsheet, and showing another, different perineal care or peri-carekit/packet thereon.

FIG. 19 shows a separated view of the components of the perineal care(or peri-care) kit or packet of FIG. 18.

FIG. 20 shows a top view of a catheterization package (e.g., similar tothe catheterization package of FIG. 17 or FIG. 18) without the perinealcare (or peri-care) kit or packet, and showing a belly band includinginstructions/procedural indicators thereon.

FIG. 21 shows a top view of a catheterization package (e.g., similar tothe catheterization package of FIG. 20 or FIG. 21) without the bellyband, and showing the sterile wrap only partially folded/wrapped arounda catheterization tray.

FIG. 22 shows a top view of the catheterization package of FIG. 22 withthe sterile wrap completely unfolded but remaining underneath thecatheterization tray, and showing the contents of the catheterizationtray before any components have been removed or, duringmanufacture/packaging, after all the components to be within the sterilewrap have been placed therein.

FIG. 23 shows a top view of the catheterization package of FIG. 23 witha package of sterile gloves partially unfolded and sitting on top of thecatheterization tray.

FIG. 24 shows a top view of the catheterization package of FIG. 24without the package of sterile gloves, and revealing a pad/drape(representative of a waterproof underpad and/or a fenestrated drape)sitting on top of the catheterization tray.

FIG. 25 shows a top view of the catheterization package of FIG. 25 withthe pad/drape moved off the swab compartment, and revealing a packet ofpovidone-iodine solution sitting in the swab compartment and extendingover the small storage or overflow compartment of the catheterizationtray.

FIG. 26 shows a top view of the catheterization package of FIG. 26without the povidone-iodine solution, and revealing the swabs orswabsticks in the swab compartment with the proximal ends of the sticksextending over the small storage or overflow compartment of thecatheterization tray.

FIG. 27 shows a top view of the catheterization package of FIG. 27 withthe syringe of sterile liquid attached to the inflation port of thecatheter.

FIG. 28 shows a top view of the catheterization package of FIG. 28 witha distal portion of the catheter positioned in the syringe or cathetercompartment and the syringe of lubricating jelly adjacent to syringe orcatheter compartment ready to dispense the lubricating jelly on top ofthe distal region or distal end of the catheter.

FIG. 29 shows a top view of the catheterization package of FIG. 29 afterthe catheter has been removed from the tray and inserted in a patient,with the drainage tubing extending in the direction of the patient.

FIG. 30A is a top view of a catheterization system;

FIG. 30B is a top view of a catheterization tray of the catheterizationsystem of FIG. 30A, which is wrapped in a wrap;

FIG. 31A is an isometric view of a catheterization tray with contentsthereof;

FIG. 31B is an isometric view of the catheterization tray of FIG. 31Awith some of the contents thereof removed therefrom;

FIG. 31C is a back isometric view of the catheterization tray of FIG.31A;

FIG. 32 is a top view of the catheterization tray of FIG. 31A with allof the contents thereof removed therefrom;

FIG. 33 is a top view of a catheterization system;

FIG. 34 is a top view of a fenestrated drape;

FIG. 35 is an isometric view of a swab;

FIG. 36A is an isometric view of a catheterization system;

FIG. 36B is an isometric view of a catheterization tray of thecatheterization system of FIG. 36A;

FIG. 37A is an isometric view of a catheterization system;

FIG. 37B is an isometric view of a partially unfolded catheterizationtray of the catheterization system of FIG. 37A; and

FIG. 37C is a partial isometric view of the unfolded catheterizationtray of the catheterization system of FIG. 37A.

FIG. 38A shows a view of another medical-procedure tray in accordancewith some embodiments.

FIG. 38B shows another view of the medical-procedure tray of FIG. 38A.

FIG. 38C shows another view of the medical-procedure tray of FIG. 38Atogether with a cover.

FIG. 38D shows another view of the medical-procedure tray of FIG. 38Atogether with a cover.

FIG. 39A shows a view of another medical-procedure tray in accordancewith some embodiments.

FIG. 39B shows another view of the medical-procedure tray of FIG. 39A.

FIG. 39C shows a view of a medical-procedure tray including a number ofretainers in a first configuration in accordance with some embodiments.

FIG. 39D shows a view of a medical-procedure tray including a number ofretainers in a second configuration in accordance with some embodiments.

FIG. 40A shows a view of another medical-procedure tray in accordancewith some embodiments.

FIG. 40B shows another view of the medical-procedure tray of FIG. 40A.

FIG. 41A shows a view of another medical-procedure tray in accordancewith some embodiments.

FIG. 41B shows another view of the medical-procedure tray of FIG. 41A.

FIG. 41C shows another view of the medical-procedure tray of FIG. 41A.

FIG. 42A shows a view of another medical-procedure tray in accordancewith some embodiments.

FIGS. 42B and 42C show other views of the medical-procedure tray of FIG.42A.

FIG. 43 shows a view of another medical-procedure tray in accordancewith some embodiments.

FIG. 44A shows a view of a removable retainer on a partition or a sideof a medical-procedure tray in accordance with some embodiments.

FIG. 44B shows another view of a removable retainer on a partition or aside of a medical-procedure tray with a concealed tab of instructions inaccordance with some embodiments.

FIG. 44C shows another view of a removable retainer on a partition or aside of a medical-procedure tray with a revealed tab of instructions inaccordance with some embodiments.

FIG. 45 shows a view of an appendage-type retainer on a side of amedical-procedure tray in accordance with some embodiments.

While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof have been shown by wayof example in the drawings and are herein described in detail. It shouldbe understood, however, that the description herein of specificembodiments is not intended to limit the invention to the particularforms disclosed, but rather the intention is to cover all modifications,equivalents, and alternatives falling within the spirit and scope of theinvention as defined by the appended claims.

DESCRIPTION

The following description and accompanying figures, which describe andshow certain embodiments, are made to demonstrate, in a non-limitingmanner, several possible configurations of medical procedure packages,medical procedure trays, catheterization packages, catheterizationtrays, and associated components, assemblies, and systems, etc. andvarious methods of manufacturing and methods of using these according tovarious aspects and features of the present disclosure.

Various packages, kits, trays, systems, assemblies, devices, and methodsare described herein, including those used in various medical procedures(including, for example, catheterization procedures). While specificembodiments are described herein by way of example, the embodiments andexamples described are not intended to be limiting. Accordingly, whileaspects of the invention may be described, for example, in terms ofcatheterization packages, catheterization trays, catheterizationprocedures, etc. disclosure is not limited to catheterization-relatedpackages, trays, systems/assemblies, procedures, etc. Rather, theinventive principles associated with the embodiments described herein,may be applied to other embodiments and other types of packages, trays,systems/assemblies, devices, methods, etc.

According to various embodiments, the objectives described above andelsewhere herein may be accomplished by providing an improved medicalprocedure package or kit including a medical procedure tray, forexample, with a more intuitive or better organized layout,instructions/procedural indicators included on the tray, etc. Forexample, an improved catheterization package or kit may be provided toimprove ease of use, improve adherence to proper techniques, reduce thelikelihood of infection, etc.

In accordance with various embodiments, the medical procedure packagemay include a medical procedure tray therein. The medical procedurepackage may also include any other components necessary or helpful tothe medical procedure. The medical procedure tray(s) contemplated hereinmay be a single level tray or have multiple levels. The medicalprocedure tray(s) may have a variety of shapes and sizes. For example, amedical procedure tray may have a generally or approximatelyrectangular, square, circular, oval, triangle, hexagonal, polygon, orother shape. As a non-limiting example, a generally rectangular medicalprocedure tray may have a length in the range from 7 inches to 20inches, a width in the range from 4 inches to 12 inches, and a height inthe range from 1 inch to 4 inches. In one embodiment, a generallyrectangular medical procedure tray (e.g., a catheterization tray similarto that shown in FIGS. 1-4) may have a length of approximately 11inches, a width of approximately 8.5 inches, and a height ofapproximately 2 inches. In one embodiment, a generally rectangularmedical procedure tray (e.g., similar to the tray shown in FIGS. 5,31A-31C, & 32) may have a length of approximately 14 inches, a width ofapproximately 8.5 inches, and a height of approximately 2.5 inches.

The medical procedure tray(s) may also include multiple sections havinga variety of shapes and sizes, any of which sections can optionally forma compartment. A section of the medical procedure tray can be designatedfor one or more particular uses (e.g., well for iodine, section forstorage, etc.), whereas a compartment can be a section at leastpartially and up to wholly separated from one or more other sections,compartments, or a combination thereof by a physical feature such as oneor more partitions. The partitions can be formed from the medicalprocedure tray itself (e.g., formed during an injection moldingprocess), and opposing faces of the partitions can be unequal in heightif separating compartments from other sections or compartments havingbottoms of higher or lower elevations. Partitions can be separatelyformed from a same material as the medical procedure tray or a differentmaterial than the medical procedure tray. The partitions can also betransiently formed from any one or more of the other componentsnecessary or helpful to the medical procedure—until the any one or moreof the other components are removed from the medical procedure tray. Forexample, with respect to components necessary or helpful tocatheterization, the one or more partitions can be transiently formedfrom a specimen or sample container, instructions/procedural indicators,or other components necessary or helpful to catheterization describedherein. Like the sections, the compartments can have a variety of shapesand sizes (e.g., the compartments may be of any of the shapes describedfor the medical procedure tray itself or of other shapes).

In accordance with various embodiments, the medical procedure packagemay be a catheterization package that includes one or morecatheterization trays therein. For example, a catheterization packagemay include an improved catheterization tray with a more intuitive orbetter organized layout and/or instructions/procedural indicatorsincluded on the tray. While various features are described below interms of a catheterization package and/or catheterization tray, thefeatures described may also be included in or applied to medicalprocedure packages and/or trays used for procedures other thancatheterization.

The catheterization package may include any components necessary orhelpful to catheterization. Some components helpful to catheterizationthat may be included in the catheterization package include a drainagesystem, a drainage/collection bag, drainage tubing, a catheter (e.g., aFoley catheter), a drainage outlet, a stabilization device (e.g., C. R.Bard, Inc.'s StatLock® Foley stabilization device), a urine meter, swabsor swabsticks, prepping balls (e.g., absorbent cotton balls), forceps, aspecimen or sample container, a label that can be filled out withdetails regarding the sample and adhered to the specimen or samplecontainer, a packet or container of an antiseptic skin cleanser (e.g., apacket or container of povidone-iodine solution), a packet or containerof lubricant (e.g., a syringe of lubricating jelly), a syringe ofsterile liquid (e.g., a 10 cc syringe of sterile water for inflating theretention balloon of the Foley catheter), a fenestrated drape to placeon patient, an underpad to place under the buttocks of a patient (e.g.,a waterproof absorbent underpad), gloves (e.g., a package of rubbergloves, latex gloves, latex-free gloves), a sterile wrap (e.g., a CSRwrap), a belly band (e.g., to hold the sterile wrap in a foldedconfiguration), a perineal care packet, hand sanitizer (e.g., antisepticgel hand rinse), moist towelettes (e.g., a package of castile soaptowelettes), instructions/procedural indicators (e.g., instruction sheetfor health care provider and/or instruction pamphlet for patient), achecklist of safety considerations/steps, a patient information chart,an insert sheet, a packaging label, an outer container (e.g., a sealedbag), and/or other components. The components included in thecatheterization package may be included in one or more compartments ofthe catheterization tray, in a separate package or bag (e.g., a packageoutside the tray), or in a second catheterization tray.

The catheterization tray(s) may be labeled with step-wiseinstructions/procedural indicators arranged in logical locations on thetray(s). The catheterization tray(s) may have a layout and design thatmakes the catheterization procedure more intuitive. A single-levelcatheterization tray having a generally rectangular shape, includingmultiple compartments of varying shapes, including step-wiseinstructions/procedural indicators, and having an improved layout isshown, for example, in FIGS. 1-4 and described below. Other similarsingle-level catheterization trays are shown in FIGS. 5, 31A-31C, & 32as well.

According to various embodiments and as shown, for example, in FIGS.1-5, the catheterization tray may include: a main compartment 1; asyringe or catheter compartment 2; a swab compartment 3; a small storageor overflow compartment 4; and a corner storage compartment 5. The trayalso includes stiffening ribs (e.g., stiffening ribs 20 shown in FIG. 2;see also stiffening ribs 205 in FIGS. 31A-31C), which help to strengthenthe tray and keep the tray from bending when held, e.g., when held byone hand.

With reference to FIGS. 1, 2, and 5, the main compartment 1 is thelargest compartment in the tray and may contain any number of items forthe catheterization procedure, for example, a drainage system, acollection bag, a drape, an underpad, an inflation syringe, and/orgloves. A drainage system that may be included in the catheterizationpackage and/or in the main compartment 1 may include, for example, adrainage/collection bag, drainage tubing, a catheter (e.g., a Foleycatheter), a drainage outlet, a urine meter, and/or other drainagesystem components. The drainage system components may be pre-connectedand stored in the catheterization package in a pre-connected state, orthe drainage system components may be stored as separate components tobe assembled/connected later.

The drainage system and tubing included in the catheterization packagemay be configured and arranged in a way that helps improve drainage ofurine through the system and tubing. For example, the tubing or othercomponents of the drainage system may be designed to break up thesurface tension of the fluid in order to improve drainage. The drainagetubing may be short to accommodate lower bed profiles or may have anadjustable length for various size beds. The tubing or other drainagesystem components may have a coating (e.g., a lubricious coating)thereon to facilitate drainage therethrough. Optionally, the tubing orother drainage system components may include a superhydrophobic patternthereon to facilitate drainage.

Additionally, there are a range of suitable durometers of the tubing orother drainage system components. However, for components that may becoiled in the tray (e.g., drainage tubing and/or the catheter), it isdesirable to have a tubing durometer that does not tend to hold a setshape at room temperature. For example, one can experiment withdifferent durometers to ensure that the durometer ultimately used forcoiled components does not tend to leave the component in a coiled shapewhen removed from the tray and put to use. It is desirable, for example,to give the drainage tubing a durometer such that, despite beingpackaged in the main compartment in a coiled state, when connected to apatient, the drainage tubing does not remain coiled, but tends tostraighten out to facilitate drainage. The drainage tubing can be madeof polyvinyl chloride (PVC), silicone, latex, Teflon, or another polymermaterial.

As shown in FIG. 1, sides 8 and 9 of the tray form two orthogonal innerwalls of the main compartment 1 and form a corner of the maincompartment 1 where the sides 8 and 9 intersect each other. Twoadditional, interior partitions 10 and 12 separate the main compartment1 from other compartments. The two interior partitions 10 and 12 includereduced height portions 14 and 16 (with reduced heights compared withthe tray's full-height partitions, inner walls, or sides).

Also, the main compartment 1 includes interior fillets 18 at the cornersformed between the floor of the main compartment 1 and its inner walls.Such fillets 18 may reinforce the corners of the main compartment 1.

As shown, for example, in FIGS. 1, 2, and 5, the main compartment of thetray may include instructions/procedural indicators and/or otherinformation integrated thereon. For example, the main compartment mayinclude a logo or trademark name written thereon, e.g., “SureStep™ FoleyTray System” and “BARD.” The main compartment may also, oralternatively, include instructions/procedural indicators related to thecatheterization printed or otherwise included thereon. For example, themain compartment may include instructions/procedural indicators for howto catheterize a patient or instructions/procedural indicators for stepsto take after catheterization. Optionally, the main compartment mayinclude instructions/procedural indicators for proper Foley care andmaintenance. As shown, for example, in FIGS. 1 and 5, theinstructions/procedural indicators integrated on the main compartmentmay include instructions/procedural indicators stating, “(1) SecureFoley with StatLock®”, “(2) position bag below bladder”, “secure tubingto sheets with clip”, “(3) document insertion date”, “(4) maintain redseal per hospital policy”, “(5) assess need for catheter routinely.” Theinstructions/procedural indicators or other information may be in uppercase letters, in bold, or otherwise called out for greater visibility toensure the clinician reads the instructions/procedural indicators orother information. Optionally, instructions/procedural indicators may beprinted or otherwise included on the main compartment to remind thehealth care provider/clinician to instruct the patient regarding how toproperly care for and maintain the catheter after catheterization. Theinstructions/procedural indicators may be written to help the healthcare provider/clinician remember to cover important instructions thatshould be given to the patient.

The syringe or catheter compartment 2 has an elongated shape and spansapproximately an entire length of the tray. Partitions and the innerwalls of the tray contribute to form the syringe or catheter compartment2. Partition 12 spans between opposing inner walls of the tray andseparates the syringe or catheter compartment 2 from othercompartments—namely, from the main compartment 1 and from the swabcompartment 3. The syringe or catheter compartment 2 is sized and shapedto contain one or more syringes (e.g., a syringe of lubricating jellyand a syringe of sterile liquid to inflate the retention balloon) and/ora catheter, such as a Foley catheter. For example, a syringe oflubricating jelly and a syringe of 10 cc sterile water may be packagedin the syringe or catheter compartment 2, but the end user (e.g., aclinician) may remove the syringes at the time of catheterization andplace the catheter in the syringe or catheter compartment 2 prior toinsertion into a patient (e.g., to facilitate lubrication of thecatheter).

A portion of the partition 12 separates the catheter compartment 2 fromthe main compartment 1. Some of the partition 12 has a full height(e.g., extends as high as the sides of the tray), but the partition 12also includes reduced height portions 16 and 22 (which have a reducedheight relative to the full height of the partition 12, inner walls, orsides of the tray). Reduced height portion 16 of the partition 12 mayact as a break or opening in the partition, which may place the syringeor catheter compartment 2 in fluid communication with the maincompartment 1 and vice versa. Along reduced height portion 16, thepartition 12 may form a small step between the syringe or cathetercompartment 2 and the main compartment 1, e.g., as shown in FIGS. 2 and6 (see also FIGS. 31A-31C). The step may also be formed by the maincompartment 1 having a lower/deeper floor than the floor of the syringeor catheter compartment 2, e.g., as shown in FIGS. 2 and 6 (see alsoFIGS. 31A-31C).

In FIGS. 1 and 2, another reduced height portion of the partition, i.e.,reduced height portion 22, separates the syringe or catheter compartment2 from the swab compartment 3. Reduced height portion 22 of thepartition 12 has a partial or reduced height relative to the full heightof the inner walls or the sides of the tray. FIG. 5 shows an alternatearrangement of reduced height portions 16, wherein both reduced heightportions 16 are located along the partition between the syringe orcatheter compartment and the main compartment (i.e., there is no reducedheight portion 22 between the syringe or catheter compartment and theswab compartment). Other arrangements and configurations are alsopossible. If syringes are packaged or included in syringe or cathetercompartment 2, the reduced height portions (e.g., reduced heightportions 16 and 22) help facilitate easy removal of the syringes fromthe syringe or catheter compartment 2 by providing more open space forthe end user to reach into the tray and grasp onto the syringes. Thismakes removal of the syringes easier than if the partition 12 did nothave any reduced height portions and the clinician had to try to graspthe syringes within a narrower region.

As shown, for example, in FIGS. 1 and 5, the syringe or cathetercompartment of the tray may also include instructions/proceduralindicators and/or other information integrated thereon. For example, thesyringe or catheter compartment may optionally includeinstructions/procedural indicators related to the catheterizationwritten thereon. As shown in FIGS. 1 and 5, the instructions/proceduralindicators integrated on the syringe or catheter compartment may includeinstructions/procedural indicators stating “Dispense & Lube Foley here”(alternatively, this instruction may simply say “Lube Foley,” “DispenseLube,” or something similar), “retract genitalia (non-dominant hand)”,“prep patient with swabs (dominant hand)”, “insert catheter & inflateballoon (dominant hand).” As shown in FIGS. 1 and 5 and as stated above,the instructions/procedural indicators may inform the health careprovider which hand to use for a given step, e.g., dominant ornon-dominant hand. The instructions/procedural indicators or otherinformation may be in upper case letters, in bold, or otherwise calledout for greater visibility to ensure the clinician reads theinstructions/procedural indicators or other information.

Note that the sides of the catheterization tray may also includeinstructions/procedural indicators or other information thereon. Forexample, as shown in FIGS. 1, 2, and 5, side 6 may include a reducedheight portion with an instruction/procedural indicator 47 to “openiodine,” while side 7 may include an instruction/procedural indicator 49to “attach water syringe.” The instructions/procedural indicators orother information may be in upper case letters, in bold, or otherwisecalled out for greater visibility to ensure the clinician reads theinstructions/procedural indicators or other information.

As shown in FIGS. 3 and 4, the base 55 of the syringe or cathetercompartment 2 may be offset from the bases of all other compartments. Inother words, the base 55 of the syringe or catheter compartment 2 may benot as deep or separated from the top of the tray as, for example, thebase 57 of the main compartment 1. As the base 55 is offset from thebases of the other compartments, the bottom/floor of the syringe orcatheter compartment is offset from bottoms/floors of the othercompartments, including being offset from the bottom/floor of the maincompartment 1.

The swab compartment 3 spans along a portion of the tray's inner wallalong side 6 of the tray; that portion of the inner wall forms a side ofthe swab compartment 3. The swab compartment 3 may contain variousitems, for example, swabs or swabsticks and one or more antiseptics suchas iodine (e.g., an iodophor such as povidone-iodine, tincture ofiodine, aqueous iodine, etc.). Portions of partition 10 and partition 12extend along two other sides of the swab compartment 3 forming two othersides of the swab compartment 3, and separate the swab compartment 3from the main compartment 1 and the syringe or catheter compartment 2,respectively. Also, the small storage or overflow compartment 4 extendsalong a fourth side of the swab compartment 3. In one embodiment asshown, for example, in FIGS. 1 and 2, the partition 10 has a full heightwhere it separates the swab compartment 3 from the main compartment 1,while the partition 12 has a reduced height (i.e., at reduced heightportion 22) that separates the swab compartment 3 from the syringe orcatheter compartment 2. In one embodiment as shown, for example, in FIG.5, the partition 10 and the partition 12 both have a full height whetherthey separate the swab compartment 3 from the main compartment 1 and thesyringe or catheter compartment 2.

The swab compartment 3 has an angled bottom/floor that spans between thesmall storage or overflow compartment 4 and the syringe or cathetercompartment 2 and has a downward slope therebetween (i.e., thebottom/floor of the swab compartment 3 near the catheter compartment 2is lower than near the storage compartment 4). As such, fluid pouredinto the swab compartment may flow in a direction toward the cathetercompartment 2 and pool in the lowest/deepest portion or well 24 of theswab compartment near the partition 12 (e.g., adjacent reduced heightportion 22 in FIGS. 1 and 2) where it separates the swab compartment 3from the catheter compartment 2. Fillets may be included in the cornersof the swab compartment 3 similar to fillets 18 in the main compartment1, e.g., as shown in FIGS. 1 and 2.

FIG. 8 shows a larger view of the swab compartment 3 and the adjacentsmall storage or overflow compartment 4 with swabs or swabstickscontained in the swab compartment 3. Near the small storage or overflowcompartment 4, the bottom/floor of the swab compartment 3 may besupported by another partition 30 (shown on FIG. 2) that separates thesmall storage or overflow compartment 4 from the swab compartment 3.Also, the partition 30 may extend upward (from the bottom/floor of thesmall storage or overflow compartment 4) only to the bottom/floor of theswab compartment 3, leaving the bottom/floor of the swab compartment 3unobstructed near the small storage or overflow compartment 4 (as such,swabs or swab sticks with a longer stick/stem may extend over a portionof the small storage or overflow compartment 4 from the bottom/floor ofswab compartment 3 as shown, for example, in FIG. 8). This design orarrangement also allows small storage or overflow compartment 4 to actas an overflow well in case too much fluid/iodine is poured into swabcompartment 3.

The swab compartment 3 includes one or more channels 28 extending atleast partially along the region between the small storage or overflowcompartment 4 and well 24 located at a bottom/floor of the swabcompartment 3. On a side of the swab compartment 3 near the cathetercompartment 2, the channels 28 extend to and are in fluid communicationwith the lowest/deepest portion of the well 24 adjacent the partition12, such that liquid poured into the channel(s) 28 can flow downwardthrough the channel(s) 28 along the downward slope and pool in thelowest/deepest portion of the well 24. The channel(s) 28 may be designedto hold an elongated device (e.g., swabs or swabsticks) and each channel28 may be separated by one or more barriers 26 to help space theelongate devices (e.g., swabs or swabsticks) apart. Channel(s) 28 mayalso include undercutting or snap-in features 32 (e.g., snap-in tabs)that may help secure elongated devices, such as swabs, swabbing sticks,or swabsticks in the channel(s) 28.

As shown, for example, in FIGS. 1, 5, and 8, the swab compartment of thetray may also include instructions/procedural indicators and/or otherinformation integrated thereon. For example, the swab compartment (e.g.,on one of barriers 26) may optionally include instructions/proceduralindicators related to the catheterization printed or otherwise includedthereon. As shown in FIGS. 1, 5, and 8, the instructions/proceduralindicators integrated on the swab compartment may include aninstruction/procedural indicator stating “pour iodine here.” Theinstructions/procedural indicators or other information may be in uppercase letters, in bold, or otherwise called out for greater visibility toensure the clinician reads the instructions/procedural indicators orother information.

One or more swabs or swabsticks (e.g., swab or swabstick 34 shown inFIGS. 6A-8) may be packaged in the swab compartment 3 and held inchannels 28 (e.g., as shown in FIG. 8). The swabs or swabsticks may bespecially designed to fit in swab compartment 3 and to be held inchannels 28. Swab compartment 3 may also include iodine orpovidone-iodine solution. The iodine or povidone-iodine solution may bepackaged in its own container, packet, or syringe in the swabcompartment 3, e.g., povidone-iodine packet 52 shown in FIG. 26.Alternatively, the iodine or povidone-iodine solution may be storedand/or sealed in swab compartment 3 in direct contact with the swab(s)or swabstick(s) 34 (e.g., packaged/sealed such that it is in contactwith a portion of the bottom/floor of swab compartment 3).

FIGS. 6A-6C show one embodiment of swab or swabstick 34 with an elongatemember or stick/stem 38 having more rounded sides (e.g., incross-section) than the swab or swabstick 34 shown in FIGS. 7A-7C. FIGS.7A-7C show one embodiment of swab or swabstick 34 with an elongatemember or stick/stem 38 having less rounded or more angular sides thanthe swab or swabstick 34 shown in FIGS. 6A-6C. Swab or swabstick 34, asshown in FIGS. 6A-7C, is representative of other possible swabs orswabsticks that may be included. Swab or swabstick 34 includes anabsorbent head 36 and an elongate member or stick/stem 38. Absorbenthead 36 is designed to allow for greater saturation in cleansingsolution (e.g., in iodine or povidone-iodine solution) and for greatercontact with the surface area of the region to be cleansed. Absorbenthead 36 may be formed from various materials, including foam, rayon(e.g., puffs of rayon or a spiral of rayon), cotton, other materials,and/or a combination of one or more of these materials. To improvesaturation of the absorbent head, the absorbent head 36 is desirablymade of a material that readily absorbs and distributes the cleansingsolution. Any material that absorbs a significant percentage of itsweight in cleansing solution is desirable for use in the absorbent head,especially if it also releases a large percentage of absorbed cleansingsolution, i.e., it is desirable to use a material that absorbs a largeamount of cleaning solution and also releases a large amount of cleaningsolution when used on the patient for cleaning. It has been found thatforming the absorbent head 36 of foam (as opposed to rayon or othermaterials) provides the absorbent head 36 with improved absorption ofand saturation with cleansing solution. Further, a foam absorbent headreadily releases a large amount of the cleansing solution when put incontact with the region of the patient to be cleansed and whencompressed slightly against the region being cleansed. This readyrelease of cleansing solution makes cleansing the region of the patienteasier and allows the end user to be more gentle when cleansing thepatient. If absorbent head 36 is made entirely or partially of foam, thefoam may be open-cell foam, closed-cell foam, polyurethane foam, highdensity foam, latex foam, honey gold foam, or other types of foam. Theabsorbent head may be heated such that it bonds to the elongate memberor stick (e.g., the foam may be heated to bond to the stick), or othermeans of attachment may be used, e.g., using an adhesive.

Preferably the foam or other material(s) selected for the absorbent headdo not degrade or at least resist degrading when in contact with thecleansing solution. In one embodiment, the swabs or swabsticks may bestored in contact with iodine or a povidone-iodine solution, so they arealready saturated when they are first accessed in the catheterizationpackage. For example, a seal may be placed in or over swab compartment 3that holds a cleansing solution in contact with the absorbent head(s) ofthe swab(s) or swabstick(s) while preventing leaks until the seal isremoved. When packaged and stored in contact with the cleansingsolution, it is vital that the absorbent head not degrade over time.Honey gold foam, for example, is sufficiently resistant to degradationwhen in contact with an iodine or povidone-iodine solution.

Absorbent head 36 may be of a variety of sizes and shapes. Preferably,the foam is shaped in such a way as to provide for greater contact withthe surface area of the region to be cleansed. For example, theabsorbent head 36 may be shaped such that the distal end or distalregion (e.g., regions that come into contact with the patient), aresubstantially larger than regions that are less likely to come intocontact with the patient (e.g., the proximal end or where the absorbenthead 36 attaches to the elongate member or stick 38). This provides moresurface area in the patient-contacting end of the absorbent head andmakes cleansing the patient quicker and easier. Further, with the distalregion of the absorbent head being larger, the majority of the iodine isabsorbed into the area that contacts the patient (in contrast, when thelargest region of the absorbent head is not at or near the distal end,much of the iodine is wastefully absorbed into a location that does notcontact or cleanse the patient). The absorbent head 36 may be shaped asshown in FIGS. 6A-7B and may be wider than it is thick. The absorbenthead 36 could also be shaped to be generally or approximately circular,rectangular, or trapezoidal. Optionally, the shape of absorbent head 36may be generally or approximately conical, pyramidal, tear drop, ovoid,or triangular in shape (with the larger base end positioned at thedistal tip of the swab or swabstick), or may be another shape. Ifgenerally pyramidal in shape, the base of the pyramidal shape may begenerally triangular, square, pentagonal, hexagonal, etc. Even ifotherwise generally conical, pyramidal, or another shape, the edges ofthe absorbent head at the distal end may be curved or tapered (e.g., asthe distal edges are curved in FIGS. 6A-7B). Further, the distal end ofthe elongate member or stick 38 may also be curved (e.g., the distal endmay be semi-circular rather than flat across the top or distal-mostedge), as curves are less likely to harm patient when cleansing with aswab or swabstick.

In one embodiment, the length of the absorbent head may be between 0.5and 2 inches (in one embodiment, the length may be approximately 1inch), the width of the absorbent head at its widest may be between 0.5and 2 inches (in one embodiment, the width at its widest may beapproximately 1 inch) and the width of the absorbent head at itsnarrowest may be between 0.1 and 1 inches (in one embodiment, the widthat its narrowest may be approximately ½ of an inch). Further, if theabsorbent head is not generally conical or pyramidal in shape (i.e.,such that its width and thickness are the same all around), it may havea thickness less than its width, e.g., a thickness between 0.1 and 1inches (in one embodiment, the thickness may be approximately ⅜ of aninch).

In one embodiment, the elongate member or stick 38 may have a lengthbetween 2 and 7 inches (e.g., the elongate member or stick 38 may have alength between 3.5 and 4.5 inches, or a length of approximately 4.25inches). The length of penetration of the stick 38 into the absorbenthead 36 (i.e., the length the stick 38 that extends distally beyond theproximal end of the absorbent head) may be between 0.25 inches and 1inch (e.g., the length of penetration may be approximately 0.5 inches).It is preferable to ensure that the length of penetration is within agood range relative to the overall length of the absorbent head. If thestick 38 extends too far into the absorbent head 36, the patient's skinmay be too easily damaged by the stick 38 (e.g., it may be more likelyto scrape against the patient during cleansing, and may not be padded byenough foam). Whereas, if the stick 38 does not extend far enough intothe absorbent head 36, the absorbent head 36 will lack structure andflop around (especially if saturated with liquid), which makes it harderfor the end user to guide the absorbent head of the swab or swabstickand effectively cleanse the patient. Ideally, the length of penetrationof the stick 38 will extend between 35 and 70% of the length of theabsorbent head 36 (e.g., the length of penetration may be about 50% ofthe length of the absorbent head). The elongate member or stick 38 maybe formed from various materials, including a plastic or polymermaterial.

The elongate member or stick 38 may have a variety of differentcross-sectional sizes and shapes. For example, the swab or swab stickmay be biased to be relatively flat or have a generally rectangularcross-section (or a rectangular-like cross-section but with roundededges as shown, for example in FIG. 6C, or with cut off edges as shown,for example, in FIG. 7C), so it is easier to hold. The elongate memberor stick 38 shown in FIGS. 6A-6C has rounded edges, but has a roughlyrectangular shape otherwise. This is a shape that is easier to hold andmanipulate while cleaning a patient than a stick with a circularcross-section. Further, this and similar cross-sectional shapes for theelongate member or stick 38 make it possible for the swabs or swabsticksto snap into the tray or be held under features 32 to prevent movementof the swabs or swabsticks during shipping or before use. To remove aswab or swabstick of this cross-section, one can simply twist theelongate member or stick 38 in a clockwise or counter clockwisedirection and the features 32 easily release the swab or swabstick foruse. For example, FIG. 8 shows two swabs or swabsticks that are snappedor held in place under the features 32, and also shows one swab orswabstick that has been twisted such that the features 32 no longer holdthe swabstick or prevent its removal. This makes the swabs or swabsticksvery secure in the swab compartment 3 during shipping and before use,but also makes removal of the swabs or swabsticks at the time ofcatheterization very simple and easy.

In one embodiment, if the elongate member or stick is of a generallyflattened (e.g., generally rectangular) shape, the width or diameter ofthe elongate member or stick 38 may be between approximately ⅛ of aninch and ¾ of an inch (e.g., the width may be about ¼ of an inch),whereas the thickness may be between 1/16 of an inch and ½ of an inch(e.g., the thickness may be approximately ⅛ of an inch). If the elongatemember or stick is of a generally circular cross-section or is generallycylindrical in shape, the diameter of the elongate member or stick 38may be between ⅛ of an inch and ½ of an inch (e.g., the diameter may beabout ¼ of an inch).

The swabs or swabsticks are loaded into the tray and held in such a waythat the absorbent head 36 is in the lowest/deepest portion or well 24of the bottom of the swab compartment 3 such that they are exposed tothe iodine that pools in the lowest/deepest portion or well 24 of thebottom of the swab compartment 3 and easily saturate with the iodine orpovidone-iodine solution. However, the elongate member or stick 38 maybe loaded into the tray and held in such a way that the elongate memberor stick 38 is not itself exposed to the iodine or povidone-iodinesolution.

The small storage or overflow compartment 4 spans along a portion of thetray's side 6, which forms an inner wall of the tray and a side of thesmall storage or overflow compartment 4. Three other sides of the smallstorage or overflow compartment 4 are formed by partial-heightpartitions that separate the small storage or overflow compartment 4from the main compartment 1, swab compartment 3, and corner compartment5. These compartments may surround the small storage or overflowcompartment 4 on three sides thereof. The small storage or overflowcompartment 4 may act as an overflow well to collect any fluid thatmight overflow from the swab compartment. Optionally, the small storageor overflow compartment 4 may store or hold one or more items useful forcatheterization.

As shown, for example, in FIGS. 1 and 5, the small storage or overflowcompartment of the tray may also include instructions/proceduralindicators and/or other information integrated thereon. For example, thesmall storage or overflow compartment may optionally includeinstructions/procedural indicators related to the catheterizationprinted or otherwise included thereon. As shown in FIGS. 1 and 5, theinformation integrated on the small storage or overflow compartment mayinclude a reminder that the health care provider/clinician should “referto directions for use for complete instructions.” Theinstructions/procedural indicators or other information may be in uppercase letters, in bold, or otherwise called out for greater visibility toensure the clinician reads the instructions/procedural indicators orother information.

The corner storage compartment 5 spans along portions of the tray's side6 and side 9, which form sides and a corner of the corner storagecompartment 5. Two other sides of the corner storage compartment 5 maybe formed by partial-height partitions that separate the corner storagecompartment 5 from the main compartment 1 (e.g., reduced height portion14) and small storage or overflow compartment 4. These compartmentssurround the corner storage compartment 5 on two sides thereof.

The bottom/floor of the corner storage compartment 5 may be non-planar;namely, the bottom/floor may have a non-planar, rounded, or partiallycylindrical shape. This shape may be particularly useful for holding aspecimen or sample container. Corner storage compartment may store orhold various implements useful for catheterization. For example, cornerstorage compartment may hold a label that can be filled out by aclinician on a first side and adhered to a specimen or sample containeron a second side. The second side may already include an adhesivethereon; the adhesive may be covered by a removable cover sheet that maybe removed at the time of adhering. The corner storage compartment mayalso include a specimen or sample container 54.

In one embodiment, at least some of the compartments may be sealed in amanner that prevents contamination thereof. In one embodiment, at leastone of the compartments may be unsealed independently of at least oneother compartment. For example, a user may first unseal the maincompartment, leaving other compartments sealed. After using itemscontained in the main compartment, the user may unseal anothercompartment and use items contained in that compartment.

In one embodiment, a user may unseal the swab compartment 3 prior tounsealing the syringe or catheter compartment 2 or the main compartment1. The user may pour iodine or another antiseptic solution into the swabcompartment and may use the swab compartment for applying the antisepticsolution onto swabs, and then use the iodine soaked swabs to cleanse thepatient. A user may then unseal the syringe or catheter compartment 2and dispense lubricant therein prior to unsealing the main compartment1. A user may then unseal the main compartment 1 to access the catheter.The shape and size of the catheter compartment facilitate lubrication ofthe catheter (e.g., a tip of the catheter can rotate within theelongated shape of the catheter compartment and collect lubricant on itssurface during the rotation). The catheter may be lubricated in thesyringe or catheter compartment 2 and then inserted into the patient'surethra.

According to various embodiments, and as shown in FIGS. 1, 2 and 5, andas discussed above, the tray may have ordered, stepwiseinstructions/procedural indicators thereon for a suitable or preferredcatheter insertion technique.

Other aspects or features of the catheterization package(s) andcatheterization tray(s) are also described below in the context ofnon-limiting procedures or methods of using the catheterization packageand catheterization tray, and in the context of methods of manufacturingor packaging a catheterization package. The aspects or featuresdescribed below may be incorporated into the various embodiments alreadydiscussed above. The arrangement of components and how they are accessedis part of the overall intuitive design of the catheterization package,i.e., components and features are arranged in a logical manner thatflows from step to step to make the catheterization procedure moreintuitive and make completing the procedure easier and/or quicker.Step-by-step ordering of the components in the catheterization packagehelps a user/clinician to logically know what step comes next. Forexample, a first item may be revealed in the package, then once thefirst item is used, a second item that was underneath the first item isrevealed, the second item being next logical item for use in thecatheterization procedure. Once the second item is used, a third itemthat was underneath the second item may be revealed, the third itembeing the next logical item for use in the catheterization procedure,and so on.

The catheterization package(s) and catheterization tray(s) describedherein may be used in many different ways. A non-limiting method of useis described below. However, clinicians may vary the steps or proceduresdescribed herein, may reorder the steps, may perform additional stepsbeyond those described, and/or may omit certain steps as circumstancesand a patient's unique needs may require. Further, the description belowcan be considered a description of an overall procedure with many stepsor can be considered a series of individual methods or procedures eachincluding only a subset of the steps described.

First, a catheterization package as shown, for example, in FIGS. 9 and10 may be provided (e.g., a health care provider/clinician may obtain orselect the catheterization package from shelf or through a purchase, ormay place the catheterization package in the hospital room where thepatient is waiting for catheterization.) As can be seen in FIGS. 9 and10, the catheterization package may be sealed, e.g., by an outercontainer 60 (e.g., a sealed bag) surrounding the other contents of thecatheterization package, such that the contents remain sterile andproperly contained. Just inside the sealed bag (or other externalcontainer), a paper or cardboard packaging label 62 may be included inthe catheterization package. The external container 60 (or sealed bag)may be transparent, or at least partially transparent, such that aclinician may see the label 62 or portions of the label. The label 62may include sides 64 that are foldable such that they extend down thesides of the catheterization package. The label may include one, two,three, or four sides. For example, FIGS. 11 and 12 each show a label 62that a large top portion 66, and 3 smaller sides or side portions 64foldable to a different plane from the plane in which the large topportion 66 resides. Lines on FIG. 12 show where the folds may be made toform the sides or side portions. In one embodiment, the label has foursides or side portions 64 instead of three.

The packaging label 62 may include instructions and or other informationthereon. For example, the label 62 may include initial instructions forcatheterization. The label 62 may include a logo, trademark, or productname printed or otherwise included thereon, e.g., “SureStep™ Foley TraySystem”, Lubrisil® I.C. Complete Care®, and/or “BARD.” The label 62 mayalso, or alternatively, include instructions related to thecatheterization written thereon. For example, the label may includeinstruction(s) 40 to verify whether the patient meets the CDC guidelinesfor indwelling urethral catheter use, as shown in the bottom leftquadrant of the top portion 66 of the labels 62 in FIGS. 9-12. The labelmay include a checklist 41 to verify the different factors that qualifya patient for indwelling urethral catheter use under the CDC guidelines,e.g., as also shown in the bottom left quadrant of the top portion 66 ofthe labels 62 shown in FIGS. 9-12. The label 62 may also include a listof components 42 of the catheterization package as shown on the rightside the top portion 66 of the labels 62 in FIGS. 9-12. The instructionsor other information may be in upper case letters, in bold, or otherwisecalled out for greater visibility to ensure the clinician reads theinstructions or other information.

The packaging label 62 may also include key information or variablescalled out in a simplified and easy-to-read manner. For example, visualidentifiers, squares, other shapes, and/or other features may beincluded that each have an indicator of one key piece of information orvariable called out and easy to read. In FIGS. 9-12, the labels 62 areshown as including information squares 44 that each includes anindicator of one key piece of information about the catheterizationpackage. Information squares 44 essentially isolate and featureparticular information about the catheterization tray from a range ofpossibilities or variables. Various features or variables may be calledout, including: (1) whether the tray includes a drainage bag or a urinemeter, (2) the French size of the catheter, (3) the type of catheterincluded, (4) the substrate type of materials used in the catheter orother components, e.g., latex or latex-free, (5) special components orfeatures, e.g., inclusion of a StatLock® securement device, inclusion ofspecial infection control coating, or other features. This calling outof particular variables, separated from everything else, allows thehealth care provider to see what is in the catheterization package ortray at a glance. Accordingly, the health care provider can quicklydetermine what the key distinguishing elements of the catheterizationpackage or tray are. For example, if the catheterization package shownin FIG. 9 and the catheterization package in FIG. 10 were both stored onthe same shelf, a health care provider could quickly tell the majordifferences between the catheterization packages just by looking at theinformation squares 44. One can readily tell from the informationsquares 44 in FIG. 9 that the catheterization package in FIG. 9 includesan 18 French sized catheter, a drainage bag, Bard's StatLock®, and is anon-latex catheter. One can readily tell from the information squares 44in FIG. 10 that the catheterization package in FIG. 10 includes a 16French sized catheter, a drainage bag, and Bard's StatLock®.

Further, the packaging label 62 may be designed to be visible inmultiple planes. The label may be designed to fold at the edges of thecatheterization package such that the label (or a portion of the label)forms sides or side portions that are visible when the catheterizationpackage is viewed from the sides, in addition to being visible from thetop. In FIGS. 9-12, the labels 62 are designed such that informationsquares 44 are visible from the top of the catheterization package, andat least two sides of the tray. Optionally, the label may also bedesigned such that information squares 44 appear on all the sides of thecatheterization package (e.g., on three sides or four sides).Accordingly, anyway you stock the catheterization package, you can seethe label. Further, multiple catheterization packages may be stacked ontop of each other, but because of the information squares on one or moresides of the catheterization package, a clinician can still quickly tellfrom the sides of the packages in the stack which catheterizationpackage from the stack is the one desired for a particular patient.

The catheterization package may be selected based on the informationsquares 44, e.g., after reviewing the information squares 44. Afterproviding/obtaining/selecting the catheterization package, the user mayopen the container (e.g., the sealed bag) and remove it from around theremainder of the catheterization package. After the container (or sealedbag) has been removed the remainder of the catheterization packagelooks, for example, as shown in FIG. 11.

The user may then remove the label 62 and set it aside to reveal othercomponents that were underneath the label 62. For example, when thelabel is removed from the catheterization packages shown in FIGS. 9-11,detailed instructions for catheterization or the directions for usedocument 68 of the catheterization package or tray may be revealed asshown, for example, in FIG. 13. Detailed instructions and/or informationon safety considerations are thereby one of the first items accessed inthe catheterization package. Providing detailed instructions up frontallows the user/clinician/health care provider to review the entireprocedure in advance of any other steps and before breaking the sterilefield formed by the CSR wrap around the catheterization tray. This helpsthe procedure to run more efficiently and safely. Pages of detailedinstructions may be seen on various pages of document 68 in FIGS.14A-14D. Any one or more of the steps contained in FIGS. 14A-14D may beperformed as a catheterization method or procedure.

Additionally, there may also be associated patient education informationwhether attached to the detailed instructions or separately placed inthe catheterization package. The patient education information may beused by a health care provider to instruct the patient on care of theindwelling catheter and may, ultimately, be given to the patient forreference. FIGS. 15A and 15B show an example of patient educationinformation that may be included on a patient sheet/pamphlet 70 in thecatheterization tray. FIG. 15A shows a first side of the patienteducation information sheet 70 in English, whereas FIG. 15B shows asecond side of the patient education information sheet 70 in Spanish.

Underneath the detailed instructions or directions for use document, thecatheterization package may include a checklist of safetyconsiderations/steps, a patient information chart, or an insert sheetincluding safety consideration/steps and a patient information chartcombined on the same insert sheet. FIG. 16 shows an insert sheet 72 onwhich patient information can be recorded or charted and includingsafety information. This insert sheet 72 may be accessed after thedetailed instructions are removed from the package. It may be beneficialto have an insert sheet 72 in this location to do one last safety checkprior to treating the patient and to have important patient informationat hand. The insert sheet 72 may be configured as a sticker label, e.g.,the insert sheet 72 may include a backing that protects a stickeradhesive, and when the backing is removed, the insert sheet 72 may bestuck to a file or chart associated with the patient.

After removing the detailed instructions 68 and the insert sheet 72 fromthe catheterization package, a perineal care (or peri-care) packet orkit 74 is revealed, as shown in FIGS. 17 and 18, and may be accessed. Aperi-care kit is helpful to provide an initial cleaning of the areawhere the catheterization takes place prior to using an iodine solutionto further cleanse and sanitize the area. This is especially true forpatients who are very dirty and must have an initial cleaning before theiodine solution will be most effective. The peri-care kit may includeany items helpful for an initial cleaning of the patient's perineum orfor perineum care in general. For example, as shown in FIGS. 18 and 19,the peri-care kit may include hand sanitizer 76 (e.g., antiseptic gelhand rinse) for the health care provider to sanitize his/her hands,moist towelettes 78 (e.g., a package of castile soap towelettes),instructions/procedural indicators 80 (e.g., instructions/proceduralindicators for health care provider and/or instructions for patient).The hand sanitizer may be designed to have improved efficacy and/or toenable single-handed usage.

As shown in FIGS. 17-19, the items of the peri-care kit may be includedin a bag 82 (e.g., a zip lock baggy) or other package to keep theitems/components together. In one embodiment, the bag type used is abaggy including a zipper 84. It has been found such a bag type is easierto open with gloves on rather than, for example, a bag without a zipperor a bag that must be opened by tearing. However, a bag withperforations on the bag instead of a zipper or zip-lock feature is alsocontemplated, as such may be cheaper to manufacture.

Peri-care instructions/procedural indicators 80 are shown in FIGS.17-19. The instructions 80 may inform a health care provider to: “1.Wash hands and don gloves,” “2. Explain procedure to patient and openPeri-Care kit,” “3. Use the provided packet of towelettes to cleanse thepatient's peri-urethral area,” and “Remove gloves and perform handhygiene with provided alcohol hand sanitizer gel.” Otherinstructions/procedural indicators are also possible. The method mayinclude performing some or all of the four steps recited above as stepson the instructions.

The method may proceed in three main stages, i.e., (A) the initialperi-care stage, (B) the catheterization stage, and (C) the cathetercare and maintenance stage. Each of these stages is denoted on theinstructions/procedural indicators and/or other materials with a large“A” “B” or “C” to signify the different main stages. As can be seen onthe peri-care instructions 80, there is a large “A” at the top of theinstructions/procedural indicators to indicate the first stage. Asdiscussed elsewhere herein, the belly band 46 includes a large “B” toindicate the second stage, and the main compartment 1 of thecatheterization tray includes a large “C” to indicate the third stage.

After removing and using the peri-care kit, a belly band/indicatorwrapper 46 may be revealed as shown in FIG. 20 (see also indicatorwrapper 140 in FIG. 30B). The belly band 46 may circumvent the tray inat least one direction. The belly band 46 may help to keep the CSR wrapintact and maintain the sterile barrier. The belly band 46 may also helpto keep all the contents inside the tray, so the items do not movearound.

The belly band/indicator wrapper 46 may include instructions/proceduralindicators and/or other information thereon. For example, as shown inFIG. 20 (see also FIG. 30B), the belly band may include aninstruction/procedural indicator telling the health care provider how toorient the tray relative to the patient. For example, the belly band maysay, “orient toward insertion site” and have an arrow pointing to theend of the catheterization tray that should be positioned closest to thepatient's perineum and urinary tract. This ensures that the tray isproperly positioned for most logical and intuitive use when the CSR wrapis opened.

Further, as shown in FIG. 20 (see also indicator wrapper 140 in FIG.30B), the belly band 46 may include instructions/procedural indicatorsto “utilize proper aseptic technique,” “(1) Open CSR Wrap,” “(2) DonSterile Gloves,” “(3) Place Underpad,” “(4) Place Fenestrated Drape,”and (5) “Follow Tray Instructions. These instructions/proceduralindicators include a large “B” at the top to signify that theseinstructions/procedural indicators are part of the second stage orcatheterization stage. The instructions/procedural indicators inform thehealth care provider to open the CSR wrap and perform other steps oncethe CSR wrap is opened. Providing this information before breaking thesterile barrier gives the health care provider a preview of theprocedure, and ensures he/she is prepared when the sterile barrier isbroken by opening the CSR wrap. Optionally, a label or sticker may beused instead of a belly-band, which may provide the same information asthe belly band described herein.

Once the tray is oriented and the health care provider has read thebelly band instructions/procedural indicators, the next step is to openand/or remove the belly band. After removing the belly band, the sterilewrap 56 (e.g., CSR wrap) may be opened. FIG. 21 shows thecatheterization tray with three corners of the sterile wrap 56 unfoldedto represent unfolding the sterile wrap 56. Note that until the bellyband and sterile wrap are opened, the sterile barrier of thecatheterization tray and its components is not broken. This maintainsthe sterile barrier while the initial peri-care stage is completed andwhile the tray is properly positioned and oriented for catheterization.By leaving the sterile barrier intact during the initial steps of themethod, there are fewer opportunities for contamination and theresulting patient infection.

If the catheterization tray is oriented as directed by the belly band46, when the sterile wrap 56 (e.g., CSR wrap) is opened, the tray isproperly oriented for logical and convenient use of the catheterizationtray and its components. The tray is arranged and ordered for logicalstep-by-step use as described herein. The initial view of the tray afteropening the sterile wrap 56 entirely is shown in FIG. 22. (A breakawayline is used to indicate that the actual edges of the sterile wrap 56extend beyond the breakaway edges shown in FIGS. 22-29.) Note that thesterile wrap 56 may remain underneath the catheterization tray to form asterile field for catheterization. The tray shown in FIG. 22 and theother figures are right-hand biased to make use easier for aright-handed health care provider when standing near the lower edge ofthe catheterization tray with the syringe or catheter compartmentpositioned furthest from the health care provider (i.e., if the bandpoints toward the genitalia between the legs, the right-handed userstands on the side closest to the patient's right leg). Alternatively, acatheterization tray may be left-hand biased (e.g., essentially a mirrorimage of the tray shown in FIGS. 22-29 with the mirror placed along thetray's side 7 or along the syringe or catheter compartment).

As instructed on the belly band 46, after first opening the CSR wrap,the health care provider next dons the sterile gloves provided in thetray. As shown in FIG. 22, the top item in the tray after the CSR wrapis opened is a package 58 of sterile gloves (note that the cuff end ofthe gloves may be indicated on the package 58). The sterile gloves maybe made of any material known to be suitable, e.g., latex, rubber, orlatex-free materials). This placement of the gloves on top of the trayunder the sterile wrap helps the health care provider to intuitivelyknow he/she should don the gloves before proceeding further (because itis intuitive, it may be unnecessary to refer back to theinstructions/procedural indicators on the belly band 46). The package ofgloves 58 may be opened by folding the cuff down to be closest to thehealth care provider and then opening the package like a book, as shownin FIG. 23. If opened in this intuitive, logical way, the left handglove is positioned on the health care provider's left side and theright hand glove is positioned on the health care provider's right sidefor easy donning of the gloves. A symbol or other indicator may beincluded on the package 58 to identify the left and right hand gloves asshown, for example, in FIG. 23.

As instructed on the belly band 46, after donning the gloves, the healthcare provider places an underpad under the patient's buttocks. As shownin FIG. 24, once the package of gloves is removed from the tray, theunderpad and fenestrated drape are revealed. The folded pad/drape 86shown in FIG. 24 is representative of: (1) a waterproof underpad, and(2) a separate fenestrated drape. The underpad may have a waterproofside and a liquid absorbent side. If so, the absorbent side is placed upunder the patient, and the waterproof side (or plastic side) is placeddown. As instructed on the belly band 46, after placing the underpad,the health care provider places the fenestrated drape on the patientsuch that the genitalia are visible through the central opening in thefenestrated drape. Although the underpad and fenestrated drape are notshown in FIG. 24 as distinct pieces, they are both included in the areaof the pad/drape 86, and are arranged such that the underpad is on topof the fenestrated drape (i.e., because the underpad is placed first,which reveals the fenestrated drape for placement thereafter). Thefenestrated drape is logically located and folded such that it isintuitive to open the drape away from clinician, which is preferable forhow the drape is best used.

As instructed on the belly band 46, after placing the fenestrated drape,the health care provider follows the instructions/procedural indicatorsand/or takes the steps written on the catheterization tray itself. Asshown in FIG. 25, removal of the underpad and fenestrated drape revealsa package of antiseptic solution 52 (e.g., povidone-iodine solution).(Note that FIG. 25 shows the fenestrated drape moved from over the swabcompartment 3 into the main compartment 1. Moving the drape in this wayor placing the fenestrated drape on the patient will reveal theantiseptic solution in the swab compartment.) Further, the firstinstruction/procedural indicator 47 on the tray (i.e., “(1) OpenIodine”; although, variations on this instruction or other instructionsare possible) is visible on the left side of the tray (which is also theside closest to the patient and the region to be catheterized, iforiented as instructed by the belly band 46). Placement of the firstinstruction 47 on the left is logical because people read English fromleft to right, and beginning instructions on the left is intuitive(although in countries that do not read left to right, this might beadjusted). Also the instruction/procedural indicator is located close tothe antiseptic or iodine solution 52 in the tray, which makes followingthe instruction/procedural indicator easier and more intuitive.

Assuming the clinician is right-handed, and has oriented the tray asinstructed by the belly band 46, the antiseptic or iodine solution 52 isautomatically positioned closest to patient. (However, as discussedabove, another arrangement is possible where the tray is left-handedbiased (e.g., essentially a mirror image of the tray in the figures)such that a left-handed user positioning the tray as instructed by thebelly band would also automatically position the antiseptic or iodinesolution closest to the patient (e.g., with the left-handed clinicianstanding on an opposite side of the tray from where a right-handedclinician would stand or on the side closest to the patient's leftleg).) Positioning the antiseptic or iodine solution (and the swabcompartment) closest to the patient is preferable for the use of thetray. Having the swab compartment 3 and well of iodine solution closestto the patient is beneficial, because it prevents dragging or movingswabs saturated with the antiseptic or iodine solution across the tray(which might drip on other components of the tray, if moved over them).

FIG. 26 shows the catheterization tray after removal of thepovidone-iodine solution. Note that removal of the packet of antisepticor iodine solution 52 reveals the swabs or swabsticks 34 and the secondinstruction/procedural indicator 48 on the tray. This intuitively leadsthe health care provider to logically follow the second instruction 48after picking up the packet of antiseptic or iodine solution. The secondinstruction 48 on the tray is in the swab compartment 3 and says “(2)Pour Iodine Here→” and points to the lowest/deepest point or well of theswab compartment 3 (although, variations of this instruction or otherinstructions are possible). If antiseptic or iodine solution is pouredon the barriers or channels of the swab compartment 3, the inclineensures the solution will flow to the lowest/deepest point or well.

Once the health care provider has poured the antiseptic or iodinesolution into the well of the swab compartment 3 such that the absorbentheads of the swabs begin absorbing the antiseptic or iodine solution,the health care provider may then attach the syringe of sterile liquid88 to the inflation port of the catheter 92 (e.g., a Foley catheter) asis instructed by the third instruction/procedural indicator 49. Thethird instruction 49 is logically located on side 7 of the tray not farfrom the well of the swab compartment where the health care provider hasjust poured the antiseptic or iodine solution, and near the syringe ofsterile liquid to be used in the third instruction. The thirdinstruction 49 states “(3) Attach Water Syringe” (although, variationson this instruction or other instructions/procedural indicators arepossible). FIG. 27 shows the syringe of sterile liquid or water 88 afterit has been attached to the inflation port of the catheter 92.

Once the syringe of sterile liquid 88 is removed from the syringe orcatheter compartment, the fourth instruction/procedural indicator 50 isrevealed (which was previously obscured by the syringe of sterileliquid). The fourth instruction 50 may inform the health care providerto “(4) Lube Catheter” or “(4) Dispense & Lube Foley Here” or somethingsimilar (again, variations on this instruction or otherinstructions/procedural indicators are possible). Indeed, lubricatingthe catheter is the next step taken by the health care provider. To doso, the health care provider removes the syringe of lubricating jelly89, which removal reveals the fifth, sixth, and seventhinstructions/procedural indicators that were previously obscured by thesyringe of lubricating jelly 89. In accordance with the presentdisclosure, the lubricating jelly can be provided in other suitablecontainers well-known to those of ordinary skill in the art, withnon-limiting examples including a bellows, an ampoule, or the like. Thehealth care provider can then lubricate the catheter in any way desired.In one embodiment, the health care provider can remove the plastic wrap90 (shown in FIGS. 27 and 28) from over the catheter 92 (which can be aFoley catheter) and move a portion of the catheter 92 into the syringeor catheter compartment 2, e.g., as shown in FIG. 28. Placing the distalend 94 of the Foley catheter 92 in the syringe or catheter compartment 2helps to line the catheter 92 up for lubrication and catheterization.For example, as shown in FIG. 28, with the distal end 94 of the catheter92 positioned near the left-most side of the syringe or cathetercompartment 2, the distal end 94 of the catheter 92 is positioned verynear the patient and the region to be catheterized (assuming the trayhas been oriented as directed by the belly band 46). Further, the distaltip of the catheter 92 is positioned such that it essentially points atthe region to be catheterized such that the health care provider maysimply lift the catheter 92 and move it a short distance in thedirection it is pointing to begin insertion of the catheter 92 into thepatient. Once the catheter 92 is positioned in the syringe or cathetercompartment 2, the user may dispense the lubricating jelly from thesyringe 89 into the syringe or catheter compartment 2 onto a distalportion of the catheter 92 (e.g., the syringe may be dispensed on theleft side of the syringe or catheter compartment near the patient andthe region to be catheterized), and twist the catheter 92 in thelubricating jelly to ensure it is properly lubricated.

While the above lubrication method is beneficial for the reasonsdiscussed above, other methods of lubricating the catheter 92 are alsopossible. In one embodiment, the health care provider may dispense thelubricating jelly onto a portion of the sterile/CSR wrap around the trayand put the end of the catheter in the lubricating jelly to lubricate.In one embodiment, the user may dispense the lubricating jelly directlyinto the syringe or catheter compartment 2 before moving the catheter 92from main compartment 1, and then move the distal portion of thecatheter 92 into the lubricating jelly.

After lubricating the catheter 92, the health care provider may leavethe catheter 92 temporarily in the syringe and catheter compartment 2while he/she uses his/her non-dominant hand to retract the genitalia,and uses his/her dominant hand to prepare and sanitize the patient withthe swabs or swabsticks saturated with antiseptic or iodine solution.The swabs or swabsticks (e.g., swabs or swabsticks 34 with absorbenthead 36 and stick 38 discussed above) may be twisted either clockwise orcounterclockwise to easily release them from the channels of the swabcompartment as discussed above. Preferably each swab or swabstick willbe used for one swipe on the patient only. For female patients, one maycleanse the patient by: (1) using a downward stroke with one swab orswabstick to cleanse the right labia minora and discard the swab orswabstick, (2) using a downward stroke with another swab or swabstick tocleanse the left labia minora and discard the swab or swabstick, and (3)using a third swab or swabstick to cleanse the middle area between thelabia minora. For male patients, one may cleanse the patient with a swabor swabstick using a circular motion starting at the urethral meatus andworking outward. After prepping and sanitizing the patient in this way,the health care provider uses his/her dominant hand to insert thecatheter into the patient's bladder (urine becomes visible in the tubingwhen the catheter enters the bladder, but two additional inches beyondthis point should be inserted to allow the retention balloon to enterthe bladder), and inflate the retention balloon in the bladder byinjecting the sterile liquid from the syringe of sterile liquid 88 intothe catheter 92 through the inflation port. Indeed, these are the stepsinstructed on the tray in the fifth step, sixth step, and seventh step,which state, respectively, “(5) Retract Genitalia (Non-Dominant Hand)”,“(6) Prep Patient with Swabs (Dominant Hand)”, and “(7) Insert Catheter& Inflate Balloon (Dominant Hand).” Variations on theseinstructions/procedural indicators or other instructions/proceduralindicators are possible. Once inflated, the health care provider maygently pull the catheter until the inflated balloon is snug against thebladder neck. These steps complete the catheterization stage or stage“B” of the procedure.

FIG. 29 shows how the tray may look immediately after the catheter hasbeen properly placed in the patient. Note that the drainage tubing 95easily follows the catheter 92 toward the patient and out of the tray. Afolded urine collection bag 96 is positioned in the main compartment 1in FIG. 29 and may be packaged pre-connected to the tubing 95, catheter92, and/or other components of the catheter assembly. Urine collectionbag 96 may be unfolded and hung below the patient to collect urine as itdrains from the patient.

After catheterization of the patient (i.e., after the catheter has beeninserted and the retention balloon inflated in the patient's bladder),additional steps may be taken. For example, in stage “C” or the Care andMaintenance stage, the health care provider may: (1) secure the Foleycatheter to the patient (e.g., using a StatLock® device), (2) positionthe urine bag and/or urine meter below the patient's bladder (e.g., hangthe bag on a hanger on the bed rail at the foot of the bed) and securethe tubing to the bed sheets (e.g., with a clip) in such a way that thetubing is not kinked, (3) document the insertion date by indicating timeand date of catheter insertion on a label and/or chart (e.g., thelabel/sheet 72 shown in FIG. 16) and document the procedure according tohospital protocol, (4) maintain the catheter (e.g., if it has a sterilered seal, then maintain the red seal), (5) re-assess the need for theindwelling catheter routinely evaluate whether the catheter becomesunnecessary, (6) and/or other care or maintenance steps.

Stage “C” and associated instructions/procedural indicators areidentified in the main compartment of the catheterization tray as shownin FIGS. 1, 2, and 5. For example, the stage “C” instructions/proceduralindicators may include: “(1) Secure Foley with StatLock®”, “(2) positionbag below bladder”, “secure tubing to sheets with clip”, “(3) documentinsertion date”, “(4) maintain red seal per hospital policy”, “(5)assess need for catheter routinely.” Variations on theseinstructions/procedural indicators or other instructions/proceduralindicators are possible. Urine samples may be taken as instructed inFIG. 14D. Ultimately, the catheter may be removed as instructed in FIG.14C.

The catheterization package(s) and catheterization tray(s) describedherein made be manufactured/packaged in different ways. For example, amanufacturer or vendor of catheterization packages may vary the steps orprocedures described herein, may reorder the steps, may performadditional steps beyond those described, and/or may omit certain stepsas circumstances and unique needs may require. Further, any features,components, arrangements, designs, ordering of components, etc.described above (e.g., features or arrangements that make using thecatheterization package more intuitive or logical) may be added to orincluded in the catheterization package during manufacturing, e.g., in amethod of manufacturing/packaging. However, non-limiting, methods ofmanufacture/packaging are described below. The steps described hereinmay be done in order as described or out of order.

In one embodiment, a catheterization package is manufactured/packaged byproviding a catheterization tray (e.g., a catheterization tray similarto or including features of those shown in FIGS. 1-5 and describedabove). The tray may be purchased or formed by the manufacturer of thecatheterization package. If manufactured, the tray may be formed usingan injection molding process or other suitable processes.Instructions/procedural indicators may be integrated on, printed, orotherwise included on the tray as described above and as shown, forexample, in FIGS. 1, 2, and 5.

Various components (e.g., any of the components discussed above orelsewhere herein) may be added to the tray. In one embodiment, apre-connected drainage system may be added to/included in the tray,e.g., in the main compartment 1 as shown in FIG. 26. The drainage systemmay include a drainage/collection bag 96, drainage tubing 95, a catheter92 (e.g., a Foley catheter), a drainage outlet, a urine meter, or otherdrainage components. Swabs or swabsticks 34 may be added to/included inthe tray, e.g., in the swab compartment 3 as shown in FIG. 8 or FIG. 26.A specimen or sample container 54 and a label that can be filled outwith details regarding the sample and adhered to the specimen or samplecontainer may be added to/included in the tray, e.g., in the cornerstorage compartment 5 as shown in FIG. 26. A packet or container of anantiseptic skin cleanser 52 (e.g., a packet or container ofpovidone-iodine solution) may be added to/included in the tray, e.g., inthe swab compartment 3 on top of the swabsticks 34 as shown in FIG. 25.A packet or container of lubricant 89 (e.g., a syringe of lubricatingjelly) may be added to/included in the tray, e.g., in the syringe orcatheter compartment 2 as shown in FIG. 26. A syringe of sterile liquid88 (e.g., a 10 cc syringe of sterile water for inflating the retentionballoon of the Foley catheter) may be added to/included in the tray,e.g., in the syringe or catheter compartment 2 on top of or partially ontop of the syringe of lubricating jelly 89 as shown in FIG. 26. Afenestrated drape to place on patient may be added to/included in thetray, e.g., on top of other components, and may span portions of morethan one compartment as shown in FIG. 24. An underpad to place under thebuttocks of a patient (e.g., a waterproof absorbent underpad) may beadded to/included in the tray, e.g., on top of the fenestrated drape orother components, and may span portions of more than one compartment.Both the underpad and fenestrated drape are represented in the figuresby pad/drape 86. Gloves (e.g., a package 58 of rubber gloves, latexgloves, latex-free gloves) may be added to/included in the tray, e.g.,on top of the underpad or other components and may span portions of morethan one compartment as shown in FIG. 22.

The tray and components may be sterilized, and a sterile wrap 56 (e.g.,a CSR wrap) may be folded or wrapped around the catheterization tray asshown in FIGS. 20-21. A belly band 46 (e.g., to hold the sterile wrap ina folded configuration and help to keep all the contents inside thetray, so the items do not move around) may be included around thesterile wrap 56 as shown in FIG. 20. A perineal care (or peri-care)packet or kit 74 (e.g., as shown in FIGS. 17-19) may be addedto/included in the catheterization package, e.g., placed over the bellyband 46 and/or sterile wrap 56 as shown in FIGS. 17 and 18. The perinealcare packet or kit 74 may include hand sanitizer 76 (e.g., antisepticgel hand rinse), moist towelettes 78 (e.g., a package of castile soaptowelettes), instructions 80 (e.g., instruction for health care providerand/or instructions for patient), and/or other components (see e.g.,FIG. 19). An insert sheet or label 72 with instructions or otherinformation may be added to/included in the catheterization package,e.g., an insert sheet or label 72 with a checklist of safetyconsiderations/steps and/or a patient information chart may be includedon top of the perineal care packet or kit as shown in FIG. 16. Adetailed instructions document (e.g., as shown in FIGS. 14A-14D) and/orpatient educational information (e.g., as shown in FIGS. 15A and 15B)may be added to/included in the catheterization package, e.g., adirections for use (DFU) document 68 and/or a patient educationalpamphlet 70 may be included on top of the insert sheet as shown in FIG.13. A packaging label 62 (e.g., a packaging label as described above andshown in FIGS. 9-12) may be added to/included in the catheterizationpackage, e.g., on top of all the other components and with edges foldingdown to cover the sides of the catheterization tray. The catheterizationpackage may be sterilized and sealed, e.g., in sealed container or bag60 as shown in FIGS. 9 and 10. Other components useful tocatheterization or care may also be included.

In one embodiment, a catheterization system may include a ureteralcatheter assembly and/or materials or supplies (e.g., catheterizationelements or components, such as sanitizer liquid, lubricant, inflationliquid, gloves, etc.) suitable or necessary for a ureteralcatheterization procedure. For instance, the catheterization system mayinclude a catheterization tray that has multiple compartments forhousing and/or securing a ureteral catheter assembly (e.g., an assemblyincluding a Foley catheter) as well as other sterile and/or non-sterilecatheterization elements, including any of those discussed above.Sterile catheterization elements may be housed in the catheterizationtray in a manner that the sterile elements remain uncontaminated bynon-sterile catheterization elements.

The catheterization tray may include one or more visual, proceduralindicators or instructions that may aid a user during thecatheterization procedure. For instance, the procedural indicators mayaid the user in orienting the catheterization tray (and catheterizationcomponents or elements thereof) relative to a patient, such that thecatheterization components and/or elements may be positioned atpredictable and suitable or desirable locations and/or orientationsrelative to the user and/or to the patient. Additionally oralternatively, the procedural indicators may aid the user in sequencinguse of the catheterization components and/or removal thereof from thecatheterization tray.

As mentioned above, the catheterization tray and system including suchtray may facilitate aseptic techniques during a catheterizationprocedure. In one embodiment, as shown in FIG. 30A, catheterizationsystem 100 includes container 110 (e.g., a sealed bag), which mayhermetically seal or contain the catheterization tray andcatheterization components. For instance, the container 110 mayfacilitate maintaining sterility of sterile catheterization components.For example, the container 110 may be a plastic bag (e.g., apolyethylene bag). Moreover, the container 110 may include a peelableside 111, which may be detached from a non-peelable side 112 to form anopening in the container 110 (container 60 above may have similarfeatures and properties); the contents located in the container 110 maybe removed through the opening.

In one embodiment, the catheterization tray and at least some of thecontents thereof (i.e., catheterization components) may be at leastpartially surrounded or enveloped by an identification cover 120. In oneembodiment, the packaging label or identification cover 120 (e.g.,similar to packaging label 62 discussed above) may include one or morevisual identifiers including key information or variables, such asvisual identifiers 121, 122, 123 (e.g., these can be similar to theinformation squares discussed above), which may provide indicationrelated to the type and/or contents of the catheterization system 100.

For example, the packaging label or identification cover 120 may befabricated from a sheet-like material, such as paper, cardboard, plastic(e.g., plastic film), etc. The visual identifiers 121, 122, 123 may beconfigured to convey sufficient information for the user to identify thespecific type of the catheterization system 100 and/or contents thereof.For instance, the visual identifier 121 may identify the size of thecatheter (e.g., 16 French, etc.). In one example, the visual identifier122 may indicate that the catheterization system 100 includes a urinemeter (which may be attached to the catheter), and/or the visualidentifier 123 may indicate that the catheterization system 100 includesa catheter stabilization device (e.g., STATLOCK).

The visual identifiers 121, 122, 123 may be visually separated orisolated one from another. For example, the visual identifiers 121, 122,123 may include a generally square or rectangular perimeter outline thatmay delimit or define the outer contours thereof. In other words, theidentifying information of the visual identifiers 121, 122, 123 may becontained within the generally rectangular outlines of the visualidentifiers 121, 122, 123. Hence, for instance, the user may easilyand/or quickly locate the pertinent information of the identificationcover 120, to identify and/or select the particular catheterizationsystem 100 suitable for the procedure.

One, some, or all of the visual identifiers 121, 122, 123 may includeany visible indications or information that may inform the user aboutspecifics of the catheterization system 100. For example, the visualidentifiers 121, 122, 123 may include text, images, symbols, etc.Moreover, the visual identifiers 121, 122, 123 and/or portions thereofmay have any suitable color or multiple colors, which may aid the userin identifying and/or distinguishing among the visual identifiers 121,122, 123. In one embodiment, at least one of the visual identifiers 121,122, 123 may have a different color than others.

It should be appreciated that the particular contour shape, size,thickness, or combinations thereof, which surrounds or contains theidentifying information of the visual identifiers 121, 122, 123 may varyfrom one embodiment to the next. As such, the visual identifiers 121,122, 123 may have generally circular, triangular, or polygonal shapes.Furthermore, the identification cover 120 may include any number ofsuitable materials that may carry the visual identifiers 121, 122, 123may vary from one embodiment to another. For instance, the visualidentifiers 121, 122, 123 may be printed, embossed, or otherwisetransferred onto the identification cover 120.

The identification cover 120 may include any number of visualidentifiers. In other words, the visual identifiers 121, 122, 123 may belocated at any number of suitable locations on the identification cover120 and/or may be duplicated. For example, the identification cover 120may include visual identifiers 121, 122, 123 on a major face thereof andon a minor face thereof. In one embodiment, the visual identifiers 121,122, 123 may be located on one, some, or all visible sides of thecatheterization system 100 (e.g., one, some, or all of the visualidentifiers 121, 122, 123 may be visible from any side of thecatheterization system 100 during storage thereof).

The identification cover 120 may be removable from the catheterizationtray. For instance, the identification cover 120 may be generallydetached from the catheterization tray (e.g., the identification cover120 may lie on the catheterization tray and may be secured relative tothe catheterization tray by the container 110). Furthermore, as shown inFIG. 30B, removing the identification cover may expose thecatheterization tray, which may be wrapped by or into a central supplyroom (CSR) sterile wrap 130. Accordingly, the CSR sterile wrap 130 mayat least temporarily secure components in the catheterization tray.

The CSR sterile wrap 130 may be unwrapped and removed from thecatheterization tray and may be used during the catheterizationprocedure. For example, the CSR sterile wrap 130 may be placed nearand/or under the patient to provide at least a partially sterileenvironment near the site of the catheterization procedure, therebyreducing risk of infections associated with the catheterizationprocedure. The CSR sterile wrap 130 may be substantially opaque, suchthat the contents of the catheterization tray and/or locationscatheterization components are obscured or not be visible to the user.Optionally, the CSR sterile wrap 130 may be translucent or transparent,such that the user may view and/or visually identify catheterizationcomponents contained in the catheterization tray.

The catheterization system 100 may include a belly band or directionalindicator wrapper 140, which may provide an indication of relativepositioning and/or orientation of the components in the catheterizationtray, which may not be visible to the user. For example, the belly bandor indicator wrapper 140 may include a direction arrow 141 that may bealigned by the user to point toward the catheter insertion site, whichmay orient the catheterization tray and catheterization componentstherein relative to the patient. For instance, orienting thecatheterization tray in a manner that aligns the direction arrow 141 inthe direction of the insertion site may position the catheterizationcomponents and/or elements at least partially sequentially, such thatthe catheterization elements and/or components to be used earlier in theprocedure are located closer to the patient than the catheterizationcomponents intended to be used later in the procedure.

In addition, the belly band or indicator wrapper 140 may include awarning indicator 142 to alert the user to proper aseptic technique forthe catheterization procedure. For example, the warning indicator 142may include one or more specific elements identifying the particularsteps suitable or necessary for proper aseptic procedure. In oneembodiment, the warning indicator 142 identifies one or more of thefollowing steps: (1) open CSR sterile wrap 130; (2) don sterile gloves;(3) place underpad; (4) place fenestrated drape; or (5) follow stepsidentified by procedure indicators located inside the catheterizationtray.

While the indicator wrapper 140 may wrap around the CSR sterile wrap130, this disclosure is not so limited. For example, a sticker or anadhesive label may be attached to the CSR sterile wrap and may includethe same or similar indicators as the indicator wrapper 140.Alternatively or additionally, the indicators may be placed directlyonto the CSR sterile wrap 130 (e.g., may be printed, embossed, orotherwise transferred thereto).

After the CSR sterile wrap 130 is removed or unwrapped from thecatheterization tray, the contents of the catheterization tray may beexposed. FIG. 31A illustrates a catheterization tray 200 of thecatheterization system 100. The catheterization tray 200 may includemultiple compartments that may secure or house various catheterizationcomponents. The shape and size of the catheterization tray 200 may bedefined by the sides thereof. For instance, sides 201, 202, 203, and 204may define an approximately rectangular outer shell or exteriorperimeter of the catheterization tray 200.

The catheterization tray 200 may be molded (e.g., injection molded,thermoformed) or stamped (e.g., from a plastic material). Hence, thesides 201, 202, 203, and 204 may be formed from a sheet-like material.One or more of the sides 201, 202, 203, or 204 may include stiffeningribs 205, which may provide rigidity and/or stiffness to the sides 201,202, 203, 204. The stiffening ribs 205 may have an approximately taperedshape and/or may protrude outward from the respective sides 201, 202,203, or 204. More specifically, for example, lower portions of thestiffening ribs 205 (portions closer to the bottom/floor of thecatheterization tray 200) may protrude out of the respective sides 201,202, 203, or 204 more than the upper portions of the stiffening ribs 205(portions closer to the opening of the catheterization tray 200). Atleast a portion of one, some, or all of the stiffening ribs 205 may havea partially conical shape.

The catheterization tray 200 may include a swab compartment 210, whichmay include one or more swabs 150 therein. Additionally oralternatively, the compartment 210 may include a cleansing/sanitizingsolution or sanitizer packet 160, which may contain one or moresanitizing agents or cleansing/sanitizing solutions (e.g., containingpovidone-iodine solution). The compartment 210 may be positioned nearand at least partially defined by the side 201 of the catheterizationtray 200. In some instances, the exterior of the sanitizer packet 160may be non-sterile. Hence, the cleansing/sanitizing solution orsanitizer packet 160 may be placed inside another packaging or a bag,which may have a sterile exterior that may prevent or reducecontamination of other catheterization components in the catheterizationtray 200 from the unsterilized packet 160 of cleansing solution orsanitizer. The plastic bag may include a zipper or similar mechanismthat may be operated by the user to open and access the packet 160and/or other components therein.

Catheterization instructions may include images and description ofvarious steps or acts taken during the catheterization procedure. Insome instances, instructions also may identify specific step or actnumbers, thereby suggesting a particular sequence of steps or acts forthe catheterization procedure. Catheterization instructions, which maybe non-sterile, may be placed into a sterile container, such as aplastic bag, thereby isolating or separating the non-sterileinstructions from sterile catheterization components in thecatheterization tray 200. Also, in some examples, the catheterizationsystem may include multiple sets of catheterization instructions, whichmay improve compliance with aseptic catheterization procedures. Forexample, catheterization instructions may could be attached or adheredto (e.g., as a sticker) inside the sterile plastic bag and/or to anothercatheterization element or component (e.g., to the sterile containerwith the sanitizer packet 160), to an exterior sleeve or portion of thecatheterization system, etc.

The compartment 210 may be configured to contained sanitizing substance(e.g., liquid), which may be dispensed in the compartment 210 from thesanitizer packet 160. For example, as described below in more detail,the compartment 210 may have a slanted bottom/floor, such that thecleansing or antiseptic solution (e.g., povidone-iodine solution) orsanitizer from the packet 160 may pool near and/or at a lowermost cornerbetween a bottom/floor and a side (e.g., partition 211) of thecompartment 210. Furthermore, tips of the swabs 150 may be located at ornear the lowermost corner between the bottom/floor and the side of thecompartment 210, such that the tips of the swabs 150 are positioned inthe dispensed sanitizing liquid.

The compartment 210 may be at least partially defined by a portion ofthe side 201 or inner wall thereof, the partition 211, by a partition212, and by the slanted bottom/floor. For instance, the lowermostportion of the compartment 210 may be located at the corner edge formedby and between the partition 211 and the slanted bottom/floor. Hence,positioning the tips/absorbent heads of the swabs 150 near the slantedbottom/floor and/or near the partition 211 of the compartment 210 maylocate the tips/absorbent heads of the swabs 150 at or near thelowermost portion of the compartment 210.

As described above, the catheterization tray 200 may be orientedrelative to the patient in a manner that places the side 201 and thecompartment 210 closer to the insertion site than the side 203 of thecatheterization tray 200. In other words, orienting the catheterizationtray 200 based on the direction arrow of the directional indicatorwrapper (while the contents and compartments of the catheterization tray200 are concealed or covered by the CSR sterile wrap 130 (FIG. 30B) mayplace the side 201 and the compartment 210 near the insertion site. Insome instances, the insertion site may be first sterilized with theswabs 150 that may be saturated with the sanitizing liquid from thesanitizer packet 160. As such, positioning the compartment 210 togetherwith the swabs 150 and sanitizer packet 160 near the insertion site mayreduce spillage of the sanitizer liquid (e.g., onto one or morecatheterization components in the catheterization tray 200) and/orcontamination of the swabs 150, which may lead to contamination of theinsertion site.

As described below in more detail, the compartment 210 may have aslanted bottom/floor. For instance, an upper edge (or surface), such asan upper edge 206 of the catheterization tray 200 may lie in animaginary plane that may be approximately parallel to a support surfacethat may support the catheterization tray 200 (e.g., surface of thepatient's bed). The slanted bottom/floor of the compartment 210 may havea non-parallel orientation relative to the imaginary plane of the upperedge 206 and/or to the support surface.

Furthermore, the bottom/floor of the compartment 210 may be non-parallelrelative to bottoms/floors of one or more other compartments in thecatheterization tray 200. For example, the catheterization tray 200 maybe set on the support surface, such that bottoms/floors of one or morecompartments support and/or orient the catheterization tray 200 on thesupport surface. Hence, as described above, the bottom/floor of thecompartment 210 may have a non-parallel orientation relative to thesupport surface.

The catheterization tray 200 may include a side compartment 220. Forexample, the compartment 220 may extend along substantially an entireside or length of the catheterization tray 200 (e.g., the compartment220 may extend between the sides 201 and 203 and/or may be partiallydefined thereby). Hence, in some instances, one side of the compartment220 may be defined by a side such as by the side 204.

The compartment 220 may contain any number of suitable elements orcomponents of the catheterization kit. For example, the compartment 220may contain a syringe 170 with liquid that may be used for inflating aballoon of the catheter (described below) and/or a syringe 180 that maycontain lubricant. As such, the width of the compartment 220 may besufficient to accommodate the syringes 170, 180. In some instances, thesyringes 170, 180 may be oriented lengthwise along the compartment 220,and may lie in a single row, one in front of the other therein.

The catheterization tray 200 may include one or more cutouts or recessesin a partition 221, which may separate the compartment 220 from anadjacent compartment(s) (e.g., from a catheter compartment 230). Forexample, one or more recesses in the partition 221 may have top edgesthereof located below the upper edge 206 of the catheterization tray200. More specifically, in some instances, the recesses may provideaccess to one or more of the syringes 170, 180 from the compartment 230.Hence, a user of the catheterization kit may remove the syringe 170and/or syringe 180 by reaching into the compartment 230, in lieu of orin addition to reaching into the compartment 220.

In one embodiment, the syringes 170 and 180 may be differently sized.Hence, in one embodiment, at least a portion of the compartment 220 maybe narrower than another portion thereof, to accommodate syringes 170,180 of different sizes. For example, compartment 210 may include anarrowing protrusion 222, which may extend into the space of thecompartment 220, thereby narrowing a portion of the compartment 220. Forinstance, the syringe 170 may have a smaller diameter or peripheral sizethan the syringe 180. Hence, the narrowing protrusion 222 may narrow thewidth of the (s) of the compartment 220 may be sufficiently wide toaccommodate the syringe 180 (e.g., the narrowing protrusion 222 mayprevent or limit lateral movement of the syringe 170 in the compartment220).

As mentioned above, the catheterization tray 200 may include the main orcatheter compartment 230. The compartment 230 may have an approximatelyrectangular shape. For example, the compartment 230 and the shapethereof may be at least partially defined by the side 203, at least aportion of the side 202, and by partitions 212, 221. While in oneembodiment the compartment 230 may have a generally rectangular shape,it should be appreciated that the shape of the compartment 230 may varyfrom one embodiment to the next.

In any event, the compartment 230 may be sized (e.g., perimeterdimensions and depth), shaped, or otherwise configured to contain orhouse a catheter assembly 190. For instance, the catheter assembly 190may include a catheter 191 that may be connected to a urine collectionbag and/or urine meter 192. In some instances, the compartment 230 alsomay contain or house a STATLOCK 193, which may secure at least a portionof the catheter assembly 190 during the catheterization procedure.

The compartment 230 may have an approximately flat or planarbottom/floor, as described below in more detail. For example, thebottom/floor of the compartment 230 may support the catheterization tray200 on the support surface. Hence, in one embodiment, the bottom/floorof the compartment 210 may have a non-parallel orientation relative tothe bottom/floor of the compartment 230.

As mentioned above, the compartment 230 may have an approximatelyrectangular shape. Furthermore, the compartment 230 may have rounded orchamfered interior corners 231 between the inner walls that define theperimeter of the compartment 230. Additionally or alternatively, theupper portions of the inner walls and/or partitions may have one or morechamfers or fillets 232, which may extend at least partially along theirrespective lengths.

The catheterization tray 200 also may include an auxiliary compartment240 that may contain or house an auxiliary container 195 (e.g., aspecimen or sample container). For instance, the auxiliary container 195may be approximately cylindrical and may include a cap. Furthermore, thecompartment 240 may be shaped, sized, and configured to secure theauxiliary container 195 therein. In one embodiment, the length of thecompartment 240 may be similar to the length of the auxiliary container195 (e.g., the compartment 240 may include a small clearance or may havean interference fit with the auxiliary container 195). In oneembodiment, the bottom/floor of the compartment 240 may besemi-cylindrical or generally arcuate and may approximately follow thegeneral cylindrical shape of the auxiliary container 195. Hence, forinstance, the bottom/floor of the compartment 240 may at least partiallywrap around the auxiliary container 195.

For example, as shown in FIG. 31B, the compartment 240 may have apartially rounded bottom/floor 241. The compartment 240 may be separatedfrom the compartment 210 in the catheterization tray 200. For instance,the catheterization tray 200 may include an overflow cavity 250 locatedbetween the compartment 240 and the compartment 210. In one embodiment,the overflow cavity 250 may form a recess or depression between thecompartment 210 and the compartment 240. For example, the overflowcavity 250 may prevent or limit overflow of the sanitizing liquiddispensed into the compartment 210. Moreover, the user may tap excesssanitizing liquid from the tips of the swabs 150 into the overflowcavity 250, before applying the sanitizing liquid at or near theinsertion site.

The slanted bottom/floor 213 of the compartment 210 may be elevated orstepped above the overflow cavity 250. For example, the slantedbottom/floor 213 may terminate at a fillet or radius 214 that may extendfrom the slanted bottom/floor 213 downward toward the overflow cavity250 or an edge thereof. The radius 214 may provide a transition betweenthe slanted bottom/floor 213 and at least a portion of the overflowcavity 250 located below the slanted bottom/floor 213. In any event, theslanted bottom/floor 213 may slant downward and away from the overflowcavity 250.

As mentioned above, sanitizing liquid may be dispensed at the lowermostportion 215 of the compartment 210 (e.g., at or near the lowermostportion of the slanted bottom/floor 213). Furthermore, sanitizing liquiddispensed in the compartment 210 may generally flow toward and pool atthe lowermost portion 215 of the compartment 210. In addition, the tips151 of the swabs 150 may be set or positioned in the sanitizing liquid.As such, the user may remove the swabs 150 from the compartment 210 andapply sanitizing liquid at the insertion site without further acts.

The swabs 150 may be secured in the compartment 210 in a manner thatpositions the tip(s) or absorbent head(s) 151 in the sanitizing liquiddispense in the compartment 210. For example, one, some, or each of theswabs 150 may include an elongated stem/stick 152 and a tip/absorbenthead 151 attached to the stem/stick 152. Moreover, the compartment 210may include channels 216 that may house and secure the elongatedstem/stick 152 of the swabs 150. Hence, the stems/sticks 152 of theswabs 150 may be secured in the channels 216 of the compartment 210.

The channels 216 may include one or more retention features (e.g.,detents, overhangs), which may secure the stems/sticks 152 therein. Forexample, the stems 152 may have approximately rectangular or generallyrectangular cross-sectional shapes. When the stems/sticks 152 areoriented along the longer side of the rectangular cross-sectional shapesthereof, the retention features may secure the elongated stem 152 in thechannels 216. Also, rotating or twisting the swabs 150 in the channels216 (e.g., such that the shorter side of the rectangular cross-sectionalshapes of the stems 152 may be oriented to lie within the channels 216)may disengage the stems 152 from the channels 216.

In other words, spacing between the retention features of the channels216 may be less than the width of the longer side of the rectangularcross-sectional shape of the elongated stem 152, such that the retentionfeatures may restrain the elongated stem/stick 152 in the channels 216.Moreover, the spacing between the retention features may be greater thanthe length of the shorter side of the rectangular cross-sectional shapeof the elongated stem/stick 152. Accordingly, twisting or rotating theswabs 150 within the channels 216 may allow the elongated stem/stick 152to pass between the retention features of the channels 216 in order toremove the elongated stem/stick 152 therefrom.

The catheterization tray 200 (as well as the catheterization trays shownin FIGS. 1-5) may be fabricated in any number of suitable ways and withany number of suitable manufacturing techniques. As mentioned above, thecatheterization tray(s) may be injection molded, thermoformed, orotherwise mass-produced. For instance, the catheterization tray(s) maybe fabricated from a sheet of plastic material that may be processed bycompressing and heating the sheet into the suitable configuration, asdescribed herein. As such, one or more of the sides of thecatheterization tray(s) may comprise a relatively thin plastic material(e.g., 0.005 inch, 0.010 inch, 0.020 inch, 0.050 inch, 0.catheterization system 100 inch, etc.). As described above, thecatheterization tray(s) may include stiffening ribs on one or more sidesthereof, which may provide rigidity to such sides.

The catheterization tray(s) may include stiffening ribs as describedherein on one or more partitions that divide the interior space of thecatheterization tray(s) into the compartments described herein. Also, asdescribed below in more detail, the partitions (e.g., the partition 221)may include folded or dual layers of sheet material. The stiffening ribsmay protrude away from the compartments (e.g., away from the compartment210, compartment 220, compartment 230) and into the space between thelayers of the sheet material.

As described above, in the compartments, the inside corners and/or edgesformed between the bottom/floor and inner walls, sides, and/orpartitions may include fillets or chamfers. For example, such fillets orchamfers may reduce stress at the inside corners or edges of thecompartments. Accordingly, the fillets and/or chamfers formed at theinside corners and/or edges of the compartments may reduce or preventbreakage or failure of the sheet material that forms the catheterizationtray 200.

The bottom/floor of the compartment 230 may be substantially flat.Additionally or alternatively, the bottom/floor of the compartment 230may have a protruding landing 232 and a recessed portion 233. Forexample, the recessed portion 233 may be lower or farther away from theupper edge 206 of the catheterization tray 200 than the landing 232.Furthermore, the recessed portion 233 may at least partially orcompletely wrap around the landing 232. As such, for instance, therecessed portion 233 may accommodate at least a portion of the catheter,which may wrap around the landing 232.

As described above, the catheterization tray 200 may be placed on asupport surface, such as a surface of the patient's bed. For example, asshown in FIG. 31C the recessed portion 233 of the compartment 230 mayform a protrusion on the exterior of the catheterization tray 200, whilethe landing 232 may form a recesses on the exterior of thecatheterization tray 200. As such, the exterior surface of the recessedportion 233 may provide or form a surface that may orient and/or supportthe catheterization tray 200 on the support surface. Moreover, in oneembodiment, the exterior surface of the recessed portion 233 may beapproximately parallel to the imaginary plane of the upper edge 206.

Also, as mentioned above, the channels 216 of the compartment 210 may begenerally parallel to the slanted bottom/floor 213 and slanted ornon-parallel relative to the support surface. The channels 216 of thecompartment 210 may have a non-parallel orientation relative to theexterior surface of the recessed portion 233. For instance, on theexterior of the catheterization tray 200, the channels 216 may protrudeoutward away from the slanted bottom/floor 213.

A compartment of the catheterization tray (e.g., compartment 210) or aportion thereof may carry the sanitizing or cleansing liquid (e.g.,povidone-iodine solution) therein. For example, at least a portion ofthe compartment may carry the sanitizing liquid and may be sealed by apeelable cover. As such, during the catheterization procedure, the usermay avoid pouring a sanitizing liquid out of a packet (e.g., into thecatheterization tray), which may prevent or reduce spillage of thesanitizing liquid. The swabs may be at least partially submerged in thesanitizing liquid and/or at least partially sealed together therewith bythe peelable cover. Alternatively or additionally, the swabs may belocated in another compartment of the catheterization tray.

As described above, partitions of the catheterization tray 200 may beformed by two layers of a sheet material. At least some of thepartitions may have space between the layers of the sheet material. Forexample, the partition 221 may include a first layer 221 a and a secondlayer 221 b spaced apart from each other (e.g., the first layer 221 amay define or form the perimeter of the compartment 230, and the secondlayer 221 b may define or form the perimeter of the compartment 220.

The stiffening ribs 205 on the first layer 221 a of the partition 221may protrude outward, away from the compartment 230 and into the spacebetween the first and second layers 221 a, 221 b. The stiffening ribs205 on the second layer 221 b may also protrude outward, away from thecompartment 220 and toward the outer perimeter or periphery of thecatheterization tray 200. In any event, as described above, thecompartments of the catheterization tray 200 may have indents thatcorrespond to the protrusions formed on the exterior portions of thecatheterization tray 200 by the stiffening ribs 205.

The catheterization tray 200 may include one or more instructions orprocedural indicators that may assist a user during a catheterizationprocedure. For instance, as illustrated in FIG. 32, the catheterizationtray 200 may include indicators 301-307, which may be printed on thecatheterization tray 200. For example, a first indicator 301 mayindicate to the user to open the package containing sanitizing liquid,and a second indicator 302 may indicate to the user to pour thesanitizing liquid into the compartment 210, during the catheterizationprocedure.

A third indicator 303 may indicate to the user to attach to the catheterthe syringe containing liquid for inflating the catheter balloon. In oneembodiment, a fourth indicator 304 may indicate to the user to dispenselubricant and/or may identify or suggest a location in the compartment220 for dispensing lubricant. Also, indicators 305-307 may identifyadditional or alternative steps to take during the catheterizationprocedure (e.g., retract genitalia (with non-dominant hand), preparepatient with swabs (with dominant hand), insert catheter and inflateballoon (with dominant hand)).

The catheterization tray 200 may include an enlarged or bolded print ofthe indicators 301-307 for improved visibility. Further, other enlargedinstructions/indicators may be printed on the bottom/floor of thecompartment 230, as shown in FIG. 32. The presence of the indicators301-307 on the catheterization tray 200 may obviate or reduce thenecessity for printed handouts or similar instructions.

In one embodiment, as shown in FIG. 33, a catheterization system 100 amay include one or more procedural indicators 260 a on a CSR sterilewrap 130 a. Except as otherwise described herein, the catheterizationsystem 100 a and its elements and components may be similar to or thesame as catheterization system 100 (FIGS. 30A-32) and its respectiveelements and components. For example the catheterization system 100 amay include the catheterization tray 200 and catheterization elementsand/or components described above in connection with the catheterizationtray 200 above.

In one embodiment, the CSR sterile wrap 130 a may include one or moreprocedural indicators 260 a that may assist a user during thecatheterization procedure. For example, one or more of the proceduralindicators 260 a may be individually isolated and/or delimited, orotherwise visually enclosed by a perimeter outline. In particular,isolating each of the procedural indicators 260 a may draw or focususer's attention thereto and may facilitate identification thereof. Theprocedural indicators 260 a may contain similar or the same informationas indicators 301-307 (FIG. 32).

In one embodiment, the catheterization tray may include a fenestrateddrape, which may partially cover the patient and may facilitateinsertion of the catheter. FIG. 34 illustrates a fenestrated drape 270.The fenestrated drape 270 may have a generally rectangular shape.Moreover, the fenestrated drape 270 may include perforations 271. Inparticular, the perforations 271 may generally form a shape of a cutoutin the fenestrated drape 270, which may be formed therein by tearing aportion of the fenestrated drape 270 delimited by the perforations 271.In one embodiment, the central portion of the fenestrated drape 270 isalready opened, i.e., the central material inside the area circumscribedby perforations 271 is removed prior to packaging the fenestrated drape270.

The shape defined by the perforations 271 or the shape of the centralopening may be suitable for accessing the genitalia of the patient forperforming the catheterization procedure after covering the patient withthe fenestrated drape 270. Also, in some instances, the fenestrateddrape 270 may include side cutouts 272. For instance, the side cutouts272 may be generally V-shaped. In one embodiment, the side cutouts 272may facilitate placement of the fenestrated drape 270 about the legs ofthe patient.

As mentioned above, the catheterization system may include variouscomponents that may facilitate the catheterization procedure, such asswabs that may facilitate sanitizing area near or at the site of thecatheterization. FIG. 35 illustrates a swab 150. For example, the swabs150 may include the elongated member or stem/stick 152 and thetip/absorbent head 151 attached thereto.

The tip/absorbent head 151 may have a generally rounded outward ordistal portion and a tapered proximal portion (e.g., tapering toward theproximal end of the tip/absorbent head 151 and toward the elongatedstem/stick 152). For example, the tip/absorbent head 151 may be narrowerat the proximal end of than at the distal portion (i.e., the distalportion may be generally flared and front edge thereof may be generallyrounded).

The tip/absorbent head 151 may include any suitable material, which mayvary from one embodiment to the next. The tip/absorbent head 151 mayinclude or comprise liquid absorbing material, which may absorbsanitizing liquid and subsequently dispense the sanitizing liquid ontoand/or near the site of catheterization. For instance, the tip/absorbenthead 151 may comprise a suitable foam, sponge, cotton, etc.

The tip/absorbent head 151 may be attached to the elongated stem/stick152 with any number of suitable mechanisms, which may vary from oneembodiment to the next. For example, the tip/absorbent head 151 may beattached to the elongated stem/stick 152 with an adhesive, may beultrasonically welded to the stem/stick 152, etc. The elongated stem 152may enter into the tip/absorbent head 151 to a predetermined depth,which may facilitate suitably securing together the tip/absorbent head151 and the elongated stem/stick 152, while leaving a sufficient portionof the tip/absorbent head 151 beyond the elongated stem/stick 152 (e.g.,in a manner that avoids contacting and/or injuring or hurting thepatient with the elongated stem/stick 152 during application of thesanitizing liquid at the insertion site. For instance, after beingsecured to the elongated stem/stick 152, the tip/absorbent head 151 mayhave sufficient flexibility and sufficient resilience and/or stiffness,such that the tip may substantially remain unbent after absorption ofthe sanitizing liquid and may resiliently bend during application of thesanitizing liquid at the insertion site.

As described above, in some examples, the catheter assembly in thecatheterization tray may be oriented generally parallel to the supportsurface that supports the catheterization tray. The catheter assembly inthe catheterization tray may be generally oriented vertically orperpendicularly to the support surface. FIGS. 36A-36B illustrate acatheterization system 100 a that includes a catheterization tray 200 a,which secures a catheter assembly and/or one or more components orelements for catheterization procedures. Except as described herein, thecatheterization system 100 a and its elements and components may besimilar to or the same catheterization system 100 (FIG. 30A) and itselements or components. For instance, except as described herein, thecatheterization tray 200 a and catheterization elements and componentscontained in the catheterization tray 200 a may be similar to thecatheterization tray 200 (FIGS. 31A-32) and catheterization elements orcomponents contained therein.

For example, as shown in FIG. 36A, the catheterization tray 200 a mayhave a generally rectangular shape, which may be defined by sides 201a-204 a. The sides 201 a-204 a may be approximately planar, hence, maydefine a box-like structure or periphery of the catheterization tray 200a. The catheterization tray 200 a also may include a top compartment 210a that may contain instructions and/or one or more catheterizationcomponents. In one embodiment, the top compartment 210 a may be definedby partitions 211 a, 212 a and a bottom 213 a. In one embodiment, thepartitions 211 a, 212 a, and/or the bottom 213 a may be removable fromthe catheterization tray 200 a.

In one embodiment, removal of the partitions 211 a, 212 a, and/or thebottom 213 a may provide access to additional catheterization componentscontained in the catheterization tray 200 a. For example, as shown inFIG. 36B, after removing the partitions 211 a, 212 a, and the bottom 213a (FIG. 36A), a center compartment 220 a of the catheterization tray 200a may be exposed and/or accessible to the user. For instance, thecompartment 220 a may house or contain catheter assembly 190. In oneembodiment, the compartment 210 a may be separated from adjacentcompartments by one or more partitions (e.g., by partitions 221 a, 222a). As mentioned above, the catheter assembly 190 in the compartment 210a may be oriented approximately vertically relative to the supportsurface (e.g., when the catheterization tray 200 a is placed on thesupport surface, such as a surface of the patient's bed).

In one embodiment, the partitions 221 a, 222 a may separate the centercompartment 220 a from adjacent compartments 230 a, 240 a. Compartments230 a and/or 240 a may house or contain various catheterization elementsor components for procedure, which may be similar to or the same ascatheterization components described above in connection withcatheterization tray 200 (FIGS. 31A-32). In some instances, thepartitions 221 and/or 222 a may be removable from the catheterizationtray 200 a, which may facilitate removal of catheterization elements orcomponents from the catheterization tray 200 a.

The catheterization tray 200 a may be constructed of any suitablematerial. For example, the catheterization tray 200 a may be constructedof thick sheet-like material or panels (e.g., plastic material). Forinstance, thickness of the panels may be in one or more of the followingranges: about 0.1 inches to about 0.2 inches; about 0.15 inches to about0.3 inches; about 0.25 inches to about 0.5 inches. It should beappreciated, however, panel thickness may be less than 0.1 inches orgreater than 0.5 inches. Moreover, the catheterization tray 200 a may bereused after the catheterization procedure (e.g., the catheterizationtray 200 a may be sanitized and/or repacked for reuse).

In one embodiment, the catheterization tray may be at least partiallydisassembled (e.g., in addition to or in lieu of removing partitions).FIG. 37A illustrates a catheterization system 100 b that may include acatheterization tray 200 b, which may be unfolded to access contentstherein. As mentioned above, the catheterization system 100 b mayinclude a catheterization tray 200 b that may be wrapped in a CSRsterile wrap 130 b, which may be unwrapped to access the catheterizationtray 200 b. For instance, initially a flap or portion 131 b of the CSRsterile wrap 130 b may be unfolded toward the patient (e.g., therebycovering the support surface with the sterile portion 131 b of the CSRsterile wrap 130 b.

In one embodiment, the CSR sterile wrap 130 b may include a pocket 132b, which may be exposed when the CSR sterile wrap 130 b is unwrapped toexpose the catheterization tray 200 b. In one embodiment, during and/orafter the catheterization procedure, used items or trash may be placedin the pocket 132 b. Subsequently, the trash may be disposed togetherwith the CSR sterile wrap 130 b.

A drape (e.g., the fenestrated drape 270) may be attached to the CSRsterile wrap 130 b, such that after the unwrapping the CSR sterile wrap130 b, the drape is exposed and may be removed from the CSR sterile wrap130 b and used in the catheterization procedure. In one embodiment, thefenestrated drape 270 may be attached to the CSR sterile wrap 130 b inany suitable manner, which may vary from one embodiment to the next. Inone example, the fenestrated drape 270 may be attached to the CSRsterile wrap 130 b with light adhesive, tape, tabs, etc.

As mentioned above, the catheterization tray 200 b may be exposed afterunwrapping the CSR sterile wrap 130 b. The catheterization tray 200 bmay include one or more identifiers 260 b, which may identify or suggestan order of step and/or use of catheterization components in thecatheterization procedure (e.g., the identifiers may be on one or moreouter surfaces of the catheterization tray 200 b). For example, theidentifiers 260 b may be located on the top surface of thecatheterization tray 200 b and may indicate further steps in thecatheterization procedure. According to one embodiment, a top panel 201b of the catheterization tray 200 b may be opened to unfold thecatheterization tray 200 b and access the catheterization components inthe catheterization tray 200 b.

As shown in FIG. 37B, after opening the catheterization tray 200 b, theuser may access the compartment 210 b, which may contain the catheterassembly 190 for the catheterization procedure. For instance, the toppanel 201 b together with a side panel 202 b (connected thereto) may beunfolded away from panels 203 b, 204 b, 205 b. More specifically, theside panels 203 b, 204 b, stiffening ribs 205 b may partially define theperiphery of the compartment 210 b. Unfolding the side panel 202 b andthe top panel 201 b from the side panels 203 b, 204 b, 205 b may provideaccess to the compartment 210 b through a side (from which the sidepanel 202 b was unfolded) and through the top (where the top panel 201 bwas removed). In one embodiment, the side panel 202 b and the top panel201 b may be unfolded in a general direction that is opposite to or awayfrom the insertion site (e.g., in a manner that would not interfere withthe catheterization procedure).

Moreover, on the interior surface of the panel 201 b, thecatheterization tray 200 b may include additional or alternativecatheterization components, such as the syringe 170 and swabs 150. Suchcatheterization components may be attached or secured to the top panel201 b and/or to the side panel 202 b. For example, the syringe 170 maybe secured to the top panel 201 b with one or more straps 220 b.Furthermore, in some instances, the swabs 150 may be secured to the toppanel 201 b within one or more pockets 230 b. It should be appreciatedthat, the catheterization components (such as the syringe 170, swabs150, etc.) may be attached or secured to the top panel 201 b in anynumber of suitable ways and with any number of suitable mechanisms(e.g., adhesive, tabs, etc.). In any event, the catheterizationcomponents secured on the interior of the top panel 201 b and/or sidepanel 202 b may be accessible and removable therefrom after unfoldingthereof away from the side panels 203 b, 204 b, 205 b.

Moreover, the side panel 202 b and/or the top panel 201 b may includeone or more procedural indicators 260 b near one or more correspondingcatheterization components. For example, procedural indicators 260 b mayidentify the catheterization components with a number that maycorrespond with a suggested number of a step in a suggested sequence ofsteps for the catheterization procedure. Also, the catheterizationcomponents and corresponding procedural indicators 260 b may be arrangedin a sequential manner, such that the indicators with higher numbers andcorresponding catheterization components are generally positionedincreasingly farther from the insertion site. In other words, thecatheterization components that are used earlier in the catheterizationprocedure may be closer to the insertion site, while the catheterizationcomponents that are used later in the catheterization procedure arelocated farther away from the insertion site (based on the orientationof the catheterization tray 200 b).

In one embodiment, the catheterization tray 200 b may include ahorizontal panel 207 b, which may be connected to and extend from theside panel 204 b (e.g., the horizontal panel 207 b may be folded intothe compartment 210 b and/or may be approximately parallel to thesupport surface supporting the catheterization tray 200 b). In someinstances, the horizontal panel 207 b may support and/or secure one ormore catheterization components. For example, the horizontal panel 207 bmay secure a pouch 180 b with lubricant that may be removed therefromand used in the catheterization procedure.

In one embodiment, the side panel 204 b and horizontal panel 207 b maybe unfolded away from the side panels 203 b and 205 b, as shown in FIG.37C. For instance, unfolding the side panel 204 b may provide accessinto the compartment 210 b. Furthermore, one or more catheterizationcomponents may be attached to the side panel 204 b and/or to theinterior side of the horizontal panel 207 b, on the interior surfacethereof. For example the sanitizer packet 160 may be attached to thehorizontal panel 207 b and/or to the side panel 204 b (e.g., with lightadhesive). Also, the catheterization tray 200 b may include indicator260 b identifying the step or particular order or place in the sequenceof the catheterization procedure where the sanitizer packet 160 may beused.

As described above, the catheterization system may include acatheterization tray wrapped into a sterile wrap, which may be usedduring the catheterization procedure. The catheterization system mayinclude one or more catheterization components packaged by and/orsecured in a sterile wrap (e.g., directly in the sterile wrap withoutthe catheterization tray). Such catheterization system may reduce wasteor materials that are thrown away after the catheterization procedure.For instance, after completing the catheterization material, the sterilewrap may be disposed and/or composted to reduce long term waste from thecatheterization system.

Following on the foregoing, FIGS. 38A, 39A, 40A, 41A, 42A, and 43Aprovide medical-procedure trays for medical-procedure packages (e.g.,catheterization trays for catheterization packages) in accordance withsome alternative embodiments to previously described medical-proceduretrays. For expository expediency, features of alternative embodimentsshared with medical-procedure trays previously described in detail abovewill not be described in similar detail below. It should be understoodthat description for each of the shared features is incorporated byreference, as appropriate, by the shared feature's name when describingalternative embodiments. For additional expository expediency, not everyfeature of alternative embodiments shared with previously describedmedical-procedure trays will be further described. Instead, it should beunderstood that shared visual elements between the alternativeembodiments and the previously described medical-procedure traysrepresent shared features between the alternative embodiments and thepreviously described medical-procedure trays. Thus, the shared visualelements provide a basis for incorporating by reference, as appropriate,description for each of the shared features for the alternativeembodiments. For example, FIGS. 2 and 38A provide medical-proceduretrays including stiffening ribs. (See stiffening ribs 20 of FIG. 2 andthe description therefor.) While the stiffening ribs of the alternativeembodiment of FIG. 38A are not expressly described, the description forthe stiffening ribs is incorporated by reference in view of the sharedvisual elements representing the stiffening ribs.

FIG. 38A shows a view of another medical-procedure tray 3800 inaccordance with some embodiments. FIG. 38B shows another view of themedical-procedure tray 3800 of FIG. 38A. FIG. 38C shows another view ofthe medical-procedure tray 3800 of FIG. 38A together with a cover 3801.FIG. 38D shows another view of the medical-procedure tray 3801 of FIG.38A together with the cover 3801.

The medical-procedure tray 3800 of FIGS. 38A, 38B, 38C, and 38D caninclude a first section 3810, a second section 3820, and a third section3830. As described herein, a section of a medical-procedure tray can bedesignated for one or more particular uses (e.g., well for iodine,section for storage, etc.), and a section can be at least partially andup to wholly separated from one or more other sections by one or morephysical features (e.g., one or more partitions), thereby forming acompartment for one or more particular uses. As shown, themedical-procedure tray 3800 includes a first partition 3842 formed fromthe medical-procedure tray 3800 itself. The first partition 3842 or atleast a first section-facing face of the first partition 3842 (see FIG.38A) has a first height h₁ equal to a height of the medical-proceduretray 3800 at least an end of the medical-procedure tray 3800 includingthe second section 3820. The first partition 3842 or at least the firstsection-facing face of the first partition 3842 (see FIG. 38A) has asecond height h₂ less than the first height at least an end of themedical-procedure tray 3800 opposite the second section 3820. In view ofthe first partition 3842, the first section 3810 can be considered afirst compartment 3810 at least partially separated from the thirdsection 3830 and wholly separated from the second section 3820. Asfurther shown, the medical-procedure tray 3800 includes a secondpartition 3844 formed from the medical-procedure tray 3800 itself. Thesecond partition 3844 or at least a third section-facing face of thesecond partition 3844 (see FIG. 38A or 38B) has a first height equal tothe height of the medical-procedure tray 3800. In view of the firstpartition 3842 and the second partition 3844, the second section 3820can be considered a second compartment 3820 wholly separated from thefirst section 3810 and the third section 3830. Further in view of thefirst partition 3842 and the second partition 3844, the third section3830 can be considered a third compartment 3830 at least partiallyseparated from the first section 3810 and wholly separated from thesecond section 3820.

As with previously described medical-procedure trays, themedical-procedure tray 3800 can include medical-procedure instructionsimprinted directly on the medical-procedure tray 3800, at least some ofwhich instructions can be revealed in step with steps of the medicalprocedure. When the medical-procedure tray 3800 is incorporated into amedical-procedure package with contents for the medical procedure (e.g.,a drainage system including a catheter, a container of lubricant, asyringe of water, a skin-preparation kit, etc. for a catheterizationprocedure), step-wise removal of the contents can reveal the step-wiseinstructions for the medical procedure imprinted on themedical-procedure tray 3800.

With respect to the first section or compartment 3810, the first section3810 can be configured to accommodate a first set of contents for amedical procedure. In some embodiments, the medical procedure is acatheterization procedure and the first set of contents can include, butis not limited to, a drainage system including a catheter (e.g., a Foleycatheter), drainage tubing, and a drainage bag. The first set ofcontents can further include a syringe of sterile water for inflating aballoon such as a balloon of a Foley catheter. When themedical-procedure tray 3800 is incorporated into a medical-procedurepackage, the first section 3810 can include the first set of contents.For a visual reference, the medical-procedure tray 3800 of FIGS. 38A,38B, 38C, and 38D is shown with a syringe of sterile water 3892. Asshown in FIGS. 38A and 38B, the syringe of sterile water 3892 can besimply placed alongside an inner wall of the medical-procedure tray 3800or fit into position alongside the inner wall with a loose-fitinterference fit at both end of the syringe of sterile water 3892. Asshown in FIGS. 38C and 38D, the syringe of sterile water 3892 can stillbe placed alongside the inner wall of the medical-procedure tray 3800;however, the syringe of sterile water 3892 can be further placed withina folded portion or retainer 3803 of the cover 3801.

Referring to FIGS. 38C and 38D, the medical-procedure tray 3800 is showntogether with the cover 3801 such as the packaging label 62 described inreference to FIGS. 11 and 12, the identification cover 120 described inreference to FIG. 30A, or a combination thereof. As further shown, thecover 3801 can be folded to form the retainer 3803 for retaining certaincontents of the medical-procedure package in the first section 3810. Forexample, the retainer 3803 can be configured for keeping the syringe ofsterile water 3892 in the first section 3810 apart from certain othercontents of the medical-procedure package in the first section 3810.Other portions of the cover 3801 can be folded to form other retainersfor retaining contents of the medical-procedure package in theappropriate sections. As shown, the cover 3801 can be configured to fitwithin the first section 3810 of the medical-procedure tray 3800;however, the cover 3801 can be alternatively configured to fit withinthe first section 3810 and additional sections (e.g., the second section3820, the third section 3830, etc.) of the medical-procedure tray 3800or portions thereof. The cover 3801 can be alternatively configured tofit over the medical-procedure tray 4100 in any of the foregoingconfigurations up to the whole medical-procedure tray 4100 exceptingfolded or otherwise shaped portions of the cover 3801 forming retainersfor retaining contents of the medical-procedure package in theappropriate sections.

With respect to the second section or compartment 3820, the secondsection 3820 can be configured to accommodate a second set of contentsfor the medical procedure. In some embodiments, the medical procedure isa catheterization procedure and the second set of contents can include,but is not limited to, a container containing lubricant (e.g., lubricantfor a Foley catheter). When the medical-procedure tray 3800 isincorporated into a medical-procedure package, the second section 3820can include the second set of contents. For a visual reference, themedical-procedure tray 3800 of FIGS. 38A and 38B is shown with acontainer of lubricant 3894.

Insofar as configuration of the second section or compartment 3820 forthe second set of contents, the second section 3820 can be configured asa retainer to retain or otherwise secure the second set of contents(e.g., the container of lubricant 3894) while simultaneously providingopen access for easy removal of the second set of contents. The secondpartition 3844 formed from the medical-procedure tray 3800 can have thepreviously described first height (e.g., equal to the height of themedical-procedure tray 3800) at the third section-facing face of thesecond partition 3844 (see FIG. 38A or 38B); however, the secondpartition 3844 can further have a second height at a secondsection-facing face of the second partition 3844. The second height atthe second section-facing face of the second partition 3844 can be lessthan the first height at the third section-facing face of the secondpartition 3844, which, in turn, serves to elevate a bottom 3822 of thesecond section 3820 above a bottom 3812 of the first section 3810 or thetray 3800 (see FIG. 38B). Again, for a visual reference, themedical-procedure tray 3800 of FIGS. 38A and 38B is shown with thecontainer of lubricant 3894. The container of lubricant 3894 can be fitinto position alongside an inner wall (or a protrusion thereof) of themedical-procedure tray 3800 shared with the second section 3820 and thesecond section-facing face of the second partition 3844 with a loose-fitinterference fit on both sides of the container of lubricant 3894, atboth ends of the container of lubricant 3894, or a combination thereof.The bottom 3822 of the second section 3820 elevated above the bottom3812 of the first section 3810 or the tray 3800 provides for the openaccess for easy removal of the second set of contents.

With respect to the third section or compartment 3830, the third section3830 can be configured to accommodate a third set of contents for themedical procedure. In some embodiments, the medical procedure is acatheterization procedure and the third set of contents can include, butis not limited to, a specimen container, optionally, a label for thespecimen container, and a skin-preparation kit including a packet ofantiseptic (e.g., an iodophor such as povidone-iodine, tincture ofiodine, aqueous iodine, etc.) and one or more swabs. When themedical-procedure tray 3800 is incorporated into a medical-procedurepackage, the third section 3830 can include the third set of contents.The medical-procedure tray 3800 of FIGS. 38A and 38B is shown withoutthe specimen container or the skin preparation kit; however, FIGS. 8,26, and 27 provide visual references for inclusion of the one or moreswabs 34 in the medical-procedure tray 3800, FIGS. 25-29 provide visualreferences for inclusion of the specimen container 54 in themedical-procedure tray 3800, and FIG. 25 provides a visual reference forinclusion of the packet of antiseptic 52 in the medical-procedure tray3800.

Insofar as configuration of the third section or compartment 3830 forthe third set of contents, the third section 3830 can be configured withone or more additional sub-sections or sub-compartments. As shown inFIGS. 38A and 38B, the one or more additional sub-sections orsub-compartments can include a swab compartment 3832, an overflowcompartment 3834, and a corner storage compartment 3836. The swabcompartment 3832, in turn, can include a well 3831 and one or morechannels, one channel of which is indicated as channel 3833. The well3831 can be positioned at a base of the second partition 3844, whichseparates the second section 3820 from the third section 3830 as shownin FIGS. 38A and 38B. The well 3831 can be further positioned at a baseof the one or more channels, thereby adjoining each channel of the oneor more channels at a well-end thereof. The well 3831 can be configuredto contain a fluid such as the antiseptic of the medical-procedurepackage when poured therein.

The one or more channels can be configured to respectively hold the oneor more swabs of the skin-preparation kit for subsequent use with theantiseptic of the packet of antiseptic. Each channel of the one or morechannels can be configured to hold a respective swab of the one or moreswabs optionally under at least one snap-in feature or snap-in tabpositioned along a length or a longitudinal side of the channel. Any twoor more snap-in tabs, such as any three or more snap-in tabs, and, forexample, any four or more snap-in tabs positioned along a length orlongitudinal sides of a channel can be staggered with respect to eachother. As shown between FIGS. 38A and 38B, each channel of the one ormore channels can include three staggered snap-in tabs along thelongitudinal sides thereof (See also FIG. 8 and the descriptiontherefor.) Each channel of the one or more channels can be furtherconfigured with an incline or an angle with respect to the bottom 3812of the tray 3800. Furthermore, each channel of the one or more channelscan be configured with a delta or delta shape at the well-end thereofadjoining the well 3831. With such a configuration, a handle end of aswab held under the snap-in tabs of a channel can be elevated withrespect to an absorbent-head end of the swab when the absorbent-head endis positioned in an accommodating delta therefor. As such, an absorbenthead of a swab can angle downwardly into the well 3831 of the swabcompartment 3832 of the third section 3830 and an elongate member of theswab can angle upwardly for gripping and removal at an appropriate stepof unboxing the medical-procedure package containing the tray 3800 andthe swab.

The overflow compartment 3834 can be positioned at an end of the one ormore channels opposite the well 3831. The overflow compartment 3834 canbe fluidly connected to the well 3831 through the one or more channels,each channel of which can be further configured to convey a fluid (e.g.,the antiseptic of the skin-preparation kit) along its length when thefluid is poured therein or thereon. Should a medical procedure requireadditional antiseptic for skin preparation or the like, the additionalantiseptic can be safely added to the well 3831 with assurance that anyvolume of antiseptic exceeding a total volume of the swab compartment3832 (e.g., a combined volume of the well 3831 and the one or morechannels) can spill into the overflow compartment 3834 via the one ormore channels.

With respect to the corner storage compartment 3836, the corner storagecan be positioned between the overflow compartment 3834 and an innerwall of the tray 3800, and, thereby share the inner wall of the tray3800. The corner storage compartment 3836 can be configured toaccommodate the specimen container of the medical-procedure package.Furthermore, while the medical-procedure package can include the packetof antiseptic in or over the swab compartment 3832 and the overflowcompartment 3834 as shown in FIG. 25, the corner storage compartment3836 can be further configured to accommodate at least a portion of thepacket of antiseptic. In such a configuration, the packet of antisepticcan be placed in or over the swab compartment 3832, the overflowcompartment 3834, the corner storage compartment 3836, or a combinationthereof in a medical-procedure package containing the tray 3800.

FIG. 39A shows a view of another medical-procedure tray 3900 inaccordance with some embodiments. FIG. 39B shows another view of themedical-procedure tray 3900 of FIG. 39A.

The medical-procedure tray 3900A of FIGS. 39A and 39B can have aconfiguration similar to the medical-procedure tray 3800 described inreference to FIGS. 38A, 38B, 38C, and 38D. As such, the tray 3900A canlikewise include a first section or first compartment 3910, a secondsection or second compartment 3920, and a third section of thirdcompartment 3930, each of which can be configured to accommodate andhold contents for a medical procedure. However, as shown, the firstsection 3910 of the tray 3900A can have a different configuration thanthe first section 3810 of the tray 3800. For example, the first section3810 of the tray 3800 of FIGS. 38A, 38B, 38C, and 38D has more of asquare-shaped footprint, whereas the first section 3910 of the tray3900A of FIGS. 39A and 39B has more of a rectangle-shaped footprint.This results from sides of the tray 3900A about the first section 3910(e.g., a side of the tray 3900A adjacent a syringe of sterile water 3892and an opposite side thereof) being longer than similar sides of thetray 3800 about the first section 3810. Configuring the first section3910 in this way allows for a comparatively larger capacity forcomparatively more contents of the medical-procedure package includingthe tray 3900A.

Not only can the first section 3910 of the tray 3900A have a differentconfiguration than the first section 3810 of the tray 3800, but one ormore partitions of the tray 3900A can have a different configurationthan the one or more partitions of the tray 3800. While not shown inFIGS. 39A and 39B, the different configuration can include adisproportionally or proportionally shorter height for the one or morepartitions of the tray 3900A compared to the one or more partitions ofthe tray 3800, which one or more partitions can have a height (e.g., amaximum height) equal to a height of the tray. For an example of adisproportionally shorter height, a first partition 3942 of the tray3900A can have a disproportionally shorter height than the firstpartition 3842 of the tray 3800, wherein an analogous first height h₁ ofthe first partition 3942 can be shorter than the first height h₁ of thefirst partition 3842, and wherein an analogous second height h₂ of thefirst partition 3942 can be substantially the same as the second heighth₂ of the first partition 3842. FIG. 41B provides a visual reference forsuch a disproportionally shorter height for the first partition 3942compared to the first partition 3842 with the understanding that thefirst partition 3942 of the tray 3900A continues to the inner wall ofthe tray 3900A as shown in FIGS. 39A and 39B. For an example of aproportionally shorter height, a second partition 3944 of the tray 3900Acan have a proportionally shorter height than the second partition 3844of the tray 3800. FIG. 41B also provides a visual reference for such aproportionally shorter height for the second partition 3944 compared tothe second partition 3844. Configuring the one or more partitions of thetray 3900A to be disproportionally or proportionally shorter in heightthan the one or more partitions of the tray 3800 allows for a bottom ofthe second section 3920 to be lower than the bottom 3822 of the secondsection 3820 of the tray 3800 while still providing open access for easyremoval of the container of lubricant 3894. For example, the bottom ofthe second section 3920 can be substantially co-planar with a bottom ofthe first section 3910 or a bottom of the tray 3900A. FIG. 41B againprovides a visual reference for such a bottom of the second section 3920of the tray 3900A with the understanding that the first partition 3942of the tray 3900A continues to the inner wall of the tray 3900A as shownin FIGS. 39A and 39B. The embodiment of the co-planar bottom of thesecond section 3920 of the tray 3900A and that of the elevated bottom3822 of the tray 3800 provide open access for easy removal of thecontainer of lubricant 3894 in that both embodiments do not have thecontainer of lubricant 3894 ensconced too deeply in a second-sectionwell.

While embodiments are disclosed for an elevated second-section bottom ofa tray (e.g., the elevated bottom 3822 of the second section 3820 of thetray 3800) and a second-section bottom co-planar with a bottom of thetray (e.g., the co-planar bottom of the second section 3920 of the tray3900A), it should be understood that a bottom of any compartment of anymedical-procedure tray disclosed herein can vary in elevation from abottom of the tray in accordance with that described for the trays 3800and 3900A.

FIG. 39C shows a view of a medical-procedure tray 3900B including anumber of retainers in a first configuration in accordance with someembodiments.

The medical-procedure tray 3900B of FIG. 39C can have a configurationsimilar to the medical-procedure tray 3900A described in reference toFIGS. 39A and 39B. As such, the tray 3900B can likewise include a firstsection 3910, a second section 3920, and a third section 3930, each ofwhich can be configured to accommodate and hold contents for a medicalprocedure. However, as shown, the first section 3910 of the tray 3900Bcan have a different configuration than the first section 3910 of thetray 3900A. For example, the first section 3910 of the tray 3900B ofFIG. 39C can have a number of retainers, one retainer of which isindicated as retainer 3912. In contrast, the first section 3910 of thetray 3900A of FIGS. 39A and 39B is shown without the number ofretainers; however, it should be understood that the tray 3900A, as wellas any tray provided herein, can optionally include one or moreretainers of any type provided herein. The number of retainers in thefirst section 3910 of the tray 3900B can be configured for retainingcertain contents of the medical-procedure package in the first section3910. For example, the number of retainers can be configured for keepingthe syringe of sterile water 3892 in the first section 3910 apart fromcertain other contents of the medical-procedure package in the firstsection 3910. Any of a number of different types of retainers (e.g.,column or tapered column-type retainers, rack-type retainers, tab-typeretainers, removable retainers, etc.) can be formed, and any of a numberof retainers (e.g., 1, 2, 3, 4, or 5 or more retainers) can beformed—some of which retainers can be formed from the tray 3900B itself.As shown, in FIG. 39C, the first section 3910 of the tray 3900B caninclude at least 3 tapered column-type retainers equidistant from theside of the tray 3900B adjacent the syringe of sterile water 3892.

FIG. 39D shows a view of a medical-procedure tray 3900C including anumber of retainers in a second configuration in accordance with someembodiments.

The medical-procedure tray 3900C of FIG. 39D can have a configurationsimilar to the medical-procedure tray 3900B described in reference toFIG. 39C. As such, the tray 3900C can likewise include a first section3910, a second section 3920, and a third section 3930, each of which canbe configured to accommodate and hold contents for a medical procedure.However, as shown, the first section 3910 of the tray 3900C can have adifferent configuration than the first section 3910 of the tray 3900B.For example, the first section 3910 of the tray 3900C of FIG. 39D cansimilarly have at least 3 tapered column-type retainers, one retainer ofwhich is indicated as retainer 3912, and another retainer of which isindicated as retainer 3913. However, in contrast to the at least 3tapered column-type retainers equidistantly spaced from the side of thetray 3900B, at least one retainer (e.g., the retainer 3913) of the atleast 3 tapered column-type retainers of the tray 3900C can be offsetfrom the others as shown by the dotted line. Such a differentconfiguration can further restrict degrees of freedom of certaincontents (e.g., the syringe of sterile water 3892) of themedical-procedure package in the first section 3910. As such, such adifferent configuration can further keep such certain contents in thefirst section 3910 apart from certain other contents of themedical-procedure package in the first section 3910.

FIG. 40A shows a view of another medical-procedure tray 4000 inaccordance with some embodiments. FIG. 40B shows another view of themedical-procedure tray 4000 of FIG. 40A.

The medical-procedure tray 4000 of FIGS. 40A and 40B can have aconfiguration similar to the medical-procedure tray 3900A described inreference to FIGS. 39A and 39B. As such, the tray 4000 can likewiseinclude a first section or first compartment 4010, a second section orsecond compartment 4020, and a third section or third compartment 4030,each of which can be configured to accommodate and hold contents for amedical procedure. However, as shown, the second section 4020 of thetray 4000 can have a different configuration than the second section3920 of the tray 3900A. For example, the second section 4020 of the tray4000 can be an extended section extending into the first section 4010,whereas the second section 3920 of the tray 3900A terminates at a commonpartition to both the second section 3920 and the third section 3930 ofthe tray 3900A, namely at the first partition 3942. The extended secondsection 4020 of the tray 4000 can be formed from an extended secondpartition 4044 extending into the first section 4010 and terminating ata third partition 4046 in the first section 4010 of the tray 4000. Inaddition, a first partition 4042 separating the third section 4030 fromthe first section 4010 can terminate at a medial portion of the extendedsecond partition 4044 instead of at an inner wall of the tray 4000. Withthe second section 4020 configured as an extended section, the extendedsecond section 4020 can accommodate more contents, larger contents, orboth as needed for a medical procedure. As shown, the extended secondsection 4020 includes a larger container of lubricant 4094 compared tothe container of lubricant 3894 shown in FIGS. 39A and 39B.

FIG. 41A shows a view of another medical-procedure tray 4100 inaccordance with some embodiments. FIG. 41B shows another view of themedical-procedure tray 4100 of FIG. 41A. FIG. 41C shows a third view ofthe medical-procedure tray 4100 of FIG. 41A.

The medical-procedure tray 4100 of FIGS. 41A, 41B, and 41C can include afirst section 4110, a second section 4120, and a third section 4130,each of which can be configured to accommodate and hold contents for amedical procedure. As described herein, a section of a medical-proceduretray can be designated for one or more particular uses, and a sectioncan be at least partially (e.g., the second section 4120) and up towholly (e.g., the third section 4130) separated from one or more othersections by one or more physical features (e.g., one or morepartitions), thereby forming a compartment for one or more particularuses. As shown, the tray 4100 includes a first partition 4142 and asecond partition 4144 wholly separating the third section 4130 from thefirst section 4110 and the second section 4120. In addition, the secondpartition 4144 partially separates the second section 4120 from thefirst section 4110. Like the medical-procedure tray 3800 of FIGS. 38Aand 38B, the first partition 4142 of the tray 4100—or at least a firstsection-facing face of the first partition 4142—can have a first heighth₁ and a second height h₂ (see FIG. 41B), and the second partition4144—or at least the third section-facing face of the second partition4144—can have a first height (not shown). Unlike the tray 3800 of FIGS.38A and 38B, the first height of the first partition 4142 and the firstheight of the second partition 4144 are, as shown, less than a height ofthe medical-procedure tray 4100. In addition, a second section-facingface of the second partition 4144 can have a height equal to the heightof the third section-facing face of the second partition 4144 making abottom of the second section 4120 co-planar with a bottom of the firstsection 4110 or the tray 4100. (See FIG. 41B.)

With respect to the first section 4110 of the tray 4100, the firstsection 4110 can be configured to accommodate a first set of contentsfor a medical procedure such as a catheterization procedure. Aspreviously described, the first set of contents can include, but is notlimited to, the drainage system including the catheter (e.g., the Foleycatheter), the drainage tubing, the drainage bag, and the syringe ofsterile water 3892 for inflating the balloon of the Foley catheter. Fora visual reference, the syringe of sterile water 3892 is shown mountedin or on a retainer (e.g., a rack-type retainer) of the first section4110 of a different type than the retainers (e.g., tapered column-typeretainers) described in reference to trays 3900B and 3900C respectivelyof FIGS. 39C and 39D. Like the number of retainers of trays 3900B and3900C, the retainer for the syringe of sterile water 3892 can be formedof the tray 4100 itself and configured to keep the syringe of sterilewater 3892 in the first section 4110 apart from other contents of themedical-procedure package in the first section 4110. The syringe ofsterile water 3892 can simply lay in the retainer or rack, or thesyringe of sterile water 3892 can be fit into the retainer or rack witha loose-fit interference fit about the syringe of sterile water 3892.

With respect to the second section 4120 of the tray 4100, the secondsection 4120 can be configured to accommodate a second set of contentsfor the medical procedure such as the catheterization procedure. Aspreviously described, the second set of contents can include, but is notlimited to, the container containing lubricant (e.g., lubricant for theFoley catheter) such as a syringe of lubricant 4194. For a visualreference, the syringe of lubricant 4194 is shown mounted in or on aretainer 4114 (e.g., a rack-type retainer) like that described inreference to the retainer in the first section 4110 for the syringe ofsterile water 3892. The syringe of lubricant 4194 can simply lay in theretainer or rack 4194, or the syringe of lubricant 4194 can be fit intothe retainer or rack 4194 with a loose-fit interference fit about thesyringe of lubricant 4194.

The retainer 4194 and the retainer for the syringe of sterile water 3892can have the same or different dimensions as required by the size of thesyringe of lubricant 4194 and the size of the syringe of sterile water3892 required by the medical procedure. When the size of the syringe oflubricant 4194 and the size of the syringe of sterile water 3892 are thesame, the retainers or racks therefor can have the same dimensions, andthe syringe of lubricant 4194 and the syringe of sterile water 3892 canbe swapped with respect to their placement in the medical-procedurepackage, for example, to better orchestrate steps of the medicalprocedure. Therefore, the second section 4120 is not limited toaccommodating and holding the syringe of lubricant 4194, and the firstsection 4110 is not limited to accommodating and holding the syringe ofsterile water 3892. The second section 4120 can be configured toaccommodate and hold the syringe of sterile water 3892, and the firstsection 4110 can be configured to accommodate the syringe of lubricant4194—even if the size of the syringe of lubricant 4194 and the size ofthe syringe of sterile water 3892 are different.

With respect to the third section 4130, the third section 4130 includesa swab compartment 4132, an overflow compartment 4134, and a cornerstorage compartment 4136 configured as described herein to accommodate athird set of contents for the medical procedure such as thecatheterization procedure. As previously described, the third set ofcontents can include, but is not limited to, the specimen container,optionally, the label for the specimen container, and theskin-preparation kit including the packet of antiseptic (e.g., aniodophor such as povidone-iodine, tincture of iodine, aqueous iodine,etc.) and the one or more swabs. The medical-procedure tray 4100 ofFIGS. 41A, 41B, and 41C is shown without the specimen container or theskin preparation kit for which the third section 4130 is configured;however, FIGS. 8, 26, and 27 provide visual references for inclusion ofthe one or more swabs 34 in the swab compartment 4132, FIGS. 25-29provide visual references for inclusion of the specimen container 54 inthe corner storage compartment 4136, and FIG. 25 provides a visualreference for inclusion of the packet of antiseptic 52 in themedical-procedure tray 4100 over the swab compartment 4132 and theoverflow compartment 4134.

Adverting to FIG. 41C, the medical-procedure tray 4100 is shown togetherwith a cover 4101 such as the packaging label 62 described in referenceto FIGS. 11 and 12, the identification cover 120 described in referenceto FIG. 30A, or a combination thereof. As shown, the cover 4101 can beconfigured to fit over the whole medical-procedure tray 4100; however,the cover 4101 can be alternatively configured to fit over a portion ofthe medical-procedure tray 4100, the portion including any one or moresections selected from the first section 4110, the second section 4120,and the third section 4130. The cover 4101 can be alternativelyconfigured to fit within the medical-procedure tray 4100 in any of theforegoing configurations such as within the whole medical-procedure tray4100 or a portion of the medical-procedure tray 4100. (See, for example,cover 3801 of FIGS. 38C and 38D.) As further shown, the tray 4100 can beconfigured with an optional support 4102 in the first section 4110 ofthe tray 4100. The support 4102 can prevent caving of the cover 4101 anddamage to the contents of the tray 4100 thereunder when one or moremedical-procedure packages are stacked on the medical-procedure packageincluding the medical-procedure tray 4100 and the cover 4101. Thesupport can be configured with a height substantially equal to a heightof the tray 4100 and a width sufficient to withstand the weight of astack of one or more medical-procedure packages stacked thereon.

FIG. 42A shows a view of another medical-procedure tray 4200 inaccordance with some embodiments. FIG. 42B shows another view of themedical-procedure tray 4200 of FIG. 42A.

The medical-procedure tray 4200 of FIGS. 42A and 42B can have aconfiguration similar to the medical-procedure tray 4100 described inreference to FIGS. 41A and 41B. As such, the tray 4200 can likewiseinclude a first section 4210, a second section 4220, and a third section4230, each of which can be configured to accommodate and hold contentsfor a medical procedure. The first section 4210, for example, can beconfigured to accommodate the previously described first set of contentsfor the catheterization procedure including the drainage systemincluding the catheter (e.g., the Foley catheter), the drainage tubing,the drainage bag, and the syringe of sterile water 3892 for inflatingthe balloon of the Foley catheter. For a visual reference, the syringeof sterile water 3892 is shown mounted in or on a rack-type retainer ofthe first section 4210. In addition, the first section can be configuredwith an optional support 4202A to prevent caving of a cover placedthereon or thereover as described herein. The second section 4220, forexample, can be configured to accommodate the previously describedsecond set of contents for the catheterization procedure including thecontainer containing lubricant (e.g., lubricant for the Foley catheter)such as a syringe of lubricant 4194. For a visual reference, the syringeof lubricant 4194 is shown mounted in or on a rack-type retainer 4214 inthe second section 4220. The third section 4230, for example, can beconfigured with a swab compartment 4232, an overflow compartment 4234,and a corner storage compartment 4236 configured as described herein toaccommodate the previously described third set of contents for thecatheterization procedure including the specimen container, optionally,the label for the specimen container, and the skin-preparation kitincluding the packet of antiseptic (e.g., an iodophor such aspovidone-iodine, tincture of iodine, aqueous iodine, etc.) and the oneor more swabs.

With respect to the third section 4230, however, the third section 4230of the tray 4200 can have a different configuration than, for example,the third section of any one tray of the trays 3800, 3900A-C, 4000, and4100 in that at least the orientation of the third section 4230 of thetray 4200 is in a reversed orientation with respect to any one tray ofthe other foregoing trays. For example, the orientation of the thirdsection 3830 of the tray 3800 is such that the well 3831 of the swabcompartment 3832 or a well-end of the third section 3830 is adjacent thesecond section 3820 of the tray 3800. In such an orientation, the cornerstorage compartment 3836 shares with the tray 3800 an inner wall of thetray 3800. In contrast, the reversed orientation of the third section4230 of the tray 4200 is such that the well (not shown) of the swabcompartment 4232 or a well-end of the third section 4230 shares with thetray 4200 an inner wall of the tray 4200. In such an orientation, thecorner storage compartment 4236 is adjacent the second section 4220 ofthe tray 4200. Any one or more of the trays provided herein includingany one or more of the trays selected from the trays 3800, 3900A-C,4000, and 4100 can be configured with a third section in the reverseorientation.

Adverting to FIG. 42B, the medical-procedure tray 4200 is shown togetherwith a cover 4201 such as the packaging label 62 described in referenceto FIGS. 11 and 12, the identification cover 120 described in referenceto FIG. 30A, or a combination thereof. As shown, the cover 4201 can beconfigured to fit over the whole medical-procedure tray 4200; however,the cover 4201 can be alternatively configured to fit over a portion ofthe medical-procedure tray 4200, the portion including any one or moresections selected from the first section 4210, the second section 4220,and the third section 4230. The cover 4201 can be alternativelyconfigured to fit within the medical-procedure tray 4200 in any of theforegoing configurations such as within the whole medical-procedure tray4200 or a portion of the medical-procedure tray 4200. (See, for example,cover 3801 of FIGS. 38C and 38D.) As further shown, the tray 4200 can beconfigured with an optional support 4202B in the first section 4110 ofthe tray 4100, which support 4202B is shown in a different location ofthe first section 4110 than the optional support 4202A of FIG. 42A. Theoptional supports 4202A and 4202B can vary in location in accordancewith packaging and stacking needs. Again, a support such as the support4202B can prevent caving of the cover 4201 and damage to the contents ofthe tray 4200 thereunder when one or more medical-procedure packages arestacked on the medical-procedure package including the medical-proceduretray 4200 and the cover 4201. Each support of the supports 4202A and4202B can be configured with a height substantially equal to a height ofthe tray 4200 and a width sufficient to withstand the weight of a stackof one or more medical-procedure packages stacked thereon.

FIG. 43 shows a view of another medical-procedure tray 4300 inaccordance with some embodiments.

The medical-procedure tray 4300 of FIG. 43 can have a configurationsimilar to the medical-procedure tray 4200 described in reference toFIGS. 42A and 42B. As such, the tray 4300 can likewise include a firstsection 4310, a second section 4320, and a third section 4330 in thereverse orientation described in reference to tray 4200. Each of thefirst section 4310, the second section 4320, and the third section 4330can be configured to accommodate and hold contents for a medicalprocedure. The first section 4310, for example, can be configured toaccommodate the previously described first set of contents for thecatheterization procedure including the drainage system including thecatheter (e.g., the Foley catheter), the drainage tubing, the drainagebag, and the syringe of sterile water for inflating the balloon of theFoley catheter. While not shown, the first section 4310 can beconfigured with a tab-type retainer to retain or otherwise secure thesyringe of sterile water. The second section 4320, for example, can beconfigured to accommodate the previously described second set ofcontents for the catheterization procedure including the containercontaining lubricant (e.g., lubricant for the Foley catheter), whichcontainer of lubricant can be retained or otherwise secured in thesecond section 4320 by a tab-type retainer 4314 in the second section4320. The reverse-orientation third section 4330, for example, can beconfigured with a swab compartment 4332, an overflow compartment 4334,and a corner storage compartment 4336 configured as described herein toaccommodate the previously described third set of contents for thecatheterization procedure including the specimen container, optionally,the label for the specimen container, and the skin-preparation kitincluding the packet of antiseptic (e.g., an iodophor such aspovidone-iodine, tincture of iodine, aqueous iodine, etc.) and the oneor more swabs. Like the tray 4200 of FIGS. 42A and 42B, the cornerstorage compartment 4336 is adjacent the second section 4320 of the tray4300; however, the second section 4320 of the tray 4300 extends from aninner wall of the first section 4310 of the tray 4300 all the way to aninner wall on an opposite side of the tray 4300 shared by the thirdsection 4330, whereas the second section 4220 of the tray 4200 does not.That being said, the second section 4220 of the tray 4200 can beconfigured to likewise extend from an inner wall of the first section4210 of the tray 4200 all the way to an inner wall on an opposite sideof the tray 4200 shared by the third section 4230.

FIG. 44A shows a view of a removable retainer 4412 on a partition or aside of a medical-procedure tray in accordance with some embodiments.FIG. 44B shows another view of the removable retainer 4412 on thepartition or the side of the medical-procedure tray with a concealed tabof instructions in accordance with some embodiments. FIG. 44C showsanother view of the removable retainer on the partition or the side ofthe medical-procedure tray with a revealed tab of instructions inaccordance with some embodiments.

Any medical-procedure tray provided herein can optionally include anynumber of retainers of any type selected from at least column or taperedcolumn-type retainers, rack-type retainers, and tab-type retainers forretaining certain contents of the medical-procedure package in theappropriate sections. For example, the tray 3900A can include threetapered column-type retainers providing the tray 3900B in which thethree tapered column-type retainers retain or otherwise keep the syringeof sterile water 3892 in the first section 3910 apart from othercontents of the medical-procedure package including the other contentsin the first section 3810. (See FIG. 39C and the retainer 3912 in thefirst section 3910 retaining the syringe 3892.) Furthermore, anymedical-procedure tray provided herein can optionally include one ormore appendage-type retainers for retaining certain contents of themedical-procedure package in the appropriate sections. For example, asshown in FIG. 45 an appendage-type retainer 4512 can include a clipsection 4593 for clipping the syringe of sterile water 3892 (or thecontainer of lubricant 3894) to the appendage-type retainer 4512, andthe appendage-type retainer 4512 can include an appending belt or strapsection 4514 for appending the clip section 4593 to either the tray(e.g., a side of the tray as shown) or a cover (e.g., an underside ofthe cover) therefor. Instructions for one or more steps of a medicalprocedure can be printed on or imprinted in a visible surface of thebelt or strap section 4514.

Whether or not a medical-procedure tray includes any of the foregoingretainers (e.g., the column or tapered column-type retainers, therack-type retainers, the tab-type retainers, and the appendage-typeretainers), the medical-procedure tray can include one or more removableretainers. An example of a removable retainer is the removable retainer4412 of FIGS. 44A, 44B, and 44C, which is configured to keep the syringeof sterile water 3892 and the container of lubricant 3894 apart fromother contents of the medical-procedure package. However, it should beunderstood that removable retainers are not limited to the removableretainer 4412. For example, a removable retainer can be configured toretain only the syringe of sterile water 3892 or only the container oflubricant 3894. Furthermore, a removable retainer can be configured toretain other contents of the medical-procedure package in theappropriate sections therefor.

As shown in FIGS. 44A, 44B, and 44C, a removable retainer such as theremovable retainer 4412 can include a clip such as clip 4414 forremovably attaching the removable retainer to a partition or a side of amedical-procedure tray. The clip can be configured to clip the removableretainer onto a partition or a side of a medical-procedure tray suchthat the removable retainer is either inside the medical-procedure tray(e.g., as packaged) or outside the medical-procedure tray (e.g., when inuse during a medical procedure). The clip can be configured to clip theremovable retainer onto a partition or a side of a medical-proceduretray with a clip force sufficient to restrict slideable movement of theremovable retainer along the side or the partition of amedical-procedure tray. Alternatively, the clip can be configured toallow such slideable movement. When the clip is configured to allowslideable movement of the removable retainer along a partition or a sideof a medical-procedure tray, less clip force or another captivatingmeans other than clip force can be used to captivate or otherwise holdthe removable retainer on the partition or the side of amedical-procedure tray until the removable retainer is deliberatelyremoved.

The slideable movement of the removable retainer can be used to revealor conceal instructions for one or more steps of a medical procedure. Asshown in FIG. 44B, a removable retainer such as the removable retainer4412 can be packaged on an inside of a medical-procedure tray concealinga folded-down tab of the instructions for the one or more steps of themedical procedure. While the folded-down tab of the instructions isshown in FIGS. 44B and 44C on an outside of the medical-procedure tray,the tray can be alternatively configured with the folded-down tab of theinstructions on the inside of the tray. Regardless of the outside or theinside configuration of the folded-down tab of the instructions, theremovable retainer can be slid aside as shown in FIG. 44B to reveal theinstructions shown in FIG. 44C, which instructions can be printed orimprinted on the tab. The instructions can again be concealed by pushingthe tab of the instructions in toward the inside or the outside of thetray and sliding the removable retainer thereover. Concealing theinstructions in the folded-down tab can reduce an amount of informationa health care provider needs to know to only the information immediatelyneeded to perform one or more immediate steps of the medical procedure.This can, in turn, reduce errors in the medical procedure. Furthermore,the folded-down tab of the instructions can further conceal sharp edgesof the tab that might otherwise compromise sterile packaging if left inan unfolded or extended position.

Again, the removable retainer 4412 of FIGS. 44A, 44B, and 44C is anexample of a removable retainer configured to keep the syringe ofsterile water 3892 and the container of lubricant 3894 apart from othercontents of the medical-procedure package. As shown in FIGS. 44A, 44B,and 44C, the removable retainer 4412 can include another, wider clip(e.g., wider than clip 4414) configured with a first clip section 4493for clipping the syringe of sterile water 3892 and a second clip section4495 for the container of lubricant 3894. Depending upon dimensions ofthe syringe of sterile water 3892 and the container of lubricant 3894,the first clip section 4493 and the second clip section 4495 can havethe same dimensions as each other or different dimensions from eachother. Regardless, the syringe of sterile water 3892 and the containerof lubricant 3894 can be arranged in the removable retainer 4412 in stepwith one or more steps of a medical procedure. For example, instructionsfor the one or more steps of the medical procedure might recommendconnecting the syringe of sterile water 3892 to a Foley catheter in afirst step, and the instructions might recommend lubricating the Foleycatheter in a second step.

While the invention has been described in terms of particular variationsand illustrative figures, those of ordinary skill in the art willrecognize that the invention is not limited to the variations or figuresdescribed. In addition, where methods and steps described above indicatecertain events occurring in certain order, those of ordinary skill inthe art will recognize that the ordering of certain steps may bemodified and that such modifications are in accordance with thevariations of the invention. Additionally, certain of the steps may beperformed concurrently in a parallel process when possible, as well asperformed sequentially as described above. Therefore, to the extentthere are variations of the invention, which are within the spirit ofthe disclosure or equivalent to the inventions found in the claims, itis the intent that this patent will cover those variations as well.

What is claimed is:
 1. A catheterization package, comprising: acatheterization tray including instructions imprinted on one or moresurfaces thereof, the catheterization tray comprising: a first sectiondefined by an outer perimeter wall and an inner partition; a secondsection separated from the first section by a first portion of the innerpartition, wherein the first portion has a first height equivalent to aheight of the outer perimeter wall defining the first section; and athird section separated from the first section by a second portion ofthe inner partition, wherein the inner partition along the secondportion includes the first height and a second height less than thefirst height, the third section including an inclined surface and a wellpositioned at a lower end of the inclined surface; a drainage systemdisposed in the first section; a syringe containing water disposedwithin the first section; a container of lubricant disposed in thesecond section; a plurality of swabs disposed in the third section onthe inclined surface, each of the plurality of swabs comprising anabsorbent head and an elongate member, wherein: the absorbent head ofeach of the plurality of swabs is positioned in the well, and theelongate member of each of the swabs extends past the inclined surfaceopposite of the well; and a sterile wrap folded around thecatheterization tray.
 2. The catheterization package of claim 1, furthercomprising: a peri-care kit packaged with the catheterization trayoutside the sterile wrap; a belly band outside the sterile wrap to holdthe sterile wrap in a folded configuration around the catheterizationtray; and a packaging label outside the sterile wrap for identifying thecatheterization package.
 3. The catheterization package of claim 1,wherein the inclined surface includes a channel configured to: i) hold aswab of the plurality of swabs; and ii) convey a fluid to the well whenthe swab is absent from the channel and the fluid is poured therein, thethird section further comprising: an overflow compartment fluidlyconnected to the well through the channel, and a corner storagecompartment holding a specimen container.
 4. The catheterization packageof claim 3, wherein the channel includes at least two snap-in tabs tohold the swab in the channel under the at least two snap-in tabs, andwherein each longitudinal side of the channel includes at least one ofthe at least two snap-in tabs.
 5. The catheterization package of claim1, wherein a bottom of the second section is elevated above a bottom ofthe first section.
 6. The catheterization package of claim 1, wherein abottom of the second section and a bottom of the first section aresubstantially co-planar.
 7. The catheterization package of claim 1,wherein the second section and the third section extend along the outerperimeter wall an equivalent distance in a length direction of thecatheterization tray.
 8. The catheterization package of claim 1, whereina syringe of sterile water is positioned along the outer perimeter wallin the first section.
 9. The catheterization package of claim 8, whereinthe syringe of sterile water is secured along the outer perimeter wallby a retainer.
 10. The catheterization package of claim 9, wherein theretainer comprises a strap coupled to the outer perimeter wall.
 11. Thecatheterization package of claim 9, wherein the retainer comprises aplurality of columns extending from a base of the first section, theplurality of columns equidistantly spaced from the outer perimeter wall.12. The catheterization package of claim 9, wherein the retainercomprises a plurality of columns extending from a base of the firstsection, one of the plurality of columns offset from a line extendingthrough at least two of the plurality of columns, the line parallel tothe outer perimeter wall along a first length.
 13. The catheterizationpackage of claim 9, wherein the retainer comprises a plurality of racksextending from a base of the first section, the plurality of rackshaving a height less than the height of the outer perimeter wall, thesyringe of sterile water mounted on the plurality of racks.
 14. Thecatheterization package of claim 9, wherein the retainer comprises aremovable clip having a first clip section designed for retaining thesyringe of sterile water.
 15. The catheterization package of claim 8,wherein the syringe of sterile water is held between the outer perimeterwall and the inner partition.
 16. The catheterization package of claim8, further comprising a cover disposed over the drainage system in thefirst section.
 17. The catheterization package of claim 16, wherein thecover includes a retainer designed to accommodate the syringe of sterilewater.
 18. A catheterization tray bounded by an outer perimeter wall,the catheterization tray comprising: a main section configured to hold aFoley catheter drainage system, the main section including a syringeretainer; a first side section configured to hold a container oflubricant; and a second side section separated from the first sidesection by a side section partition, the second side section includingan inclined surface; and a continuous main section partition separatingthe main section from the first side section and the second sidesection.
 19. The catheterization tray of claim 18, further comprisinginstructions printed on a bottom surface of the main section, the firstside section, and the second side section.
 20. The catheterization trayof claim 18, wherein the second side section further comprises a well ata lower end of the inclined surface, and an overflow compartmentadjacent an upper end of the inclined surface.
 21. The catheterizationtray of claim 20, wherein the second side section further comprises aspecimen container compartment adjacent the overflow compartment. 22.The catheterization tray of claim 18, wherein the inclined surfaceincludes a plurality of channels, each of the plurality of channelsincluding one or more snap-in tabs configured to releasably retain anelongate member of a swab.
 23. The catheterization tray of claim 18,wherein the syringe retainer comprises a strap coupled to the outerperimeter wall.
 24. The catheterization tray of claim 18, wherein thesyringe retainer comprises a plurality of columns extending from abottom surface of the main section, the plurality of columnsequidistantly spaced from the outer perimeter wall.
 25. Thecatheterization tray of claim 18, wherein the syringe retainer comprisesa plurality of columns extending from a bottom surface of the mainsection, one of the plurality of columns offset from a line extendingthrough at least two of the plurality of columns, the line parallel tothe outer perimeter wall.
 26. The catheterization tray of claim 18,wherein the syringe retainer comprises a plurality of racks extendingfrom a bottom surface of the main section, the plurality of racks havinga height less than a height of the outer perimeter wall.
 27. Thecatheterization tray of claim 18, wherein the syringe retainer comprisesa removable clip having a first clip section designed for retaining thesyringe.